Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-03-13 @ 8:47 AM
Study NCT ID:
NCT03437512
Status:
TERMINATED
Last Update Posted:
2021-04-29
First Post:
2018-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-invasive Brain Stimulation in Adults Who Stutter
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013342', 'term': 'Stuttering'}, {'id': 'D013060', 'term': 'Speech'}], 'ancestors': [{'id': 'D013064', 'term': 'Speech Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014705', 'term': 'Verbal Behavior'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'emilyog@med.umich.edu', 'phone': '734-232-3371', 'title': 'Emily O. Garnett, PhD, CCC-SLP', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study was terminated early due to pandemic research pause, which resulted in fewer enrolled subjects than anticipated, which affected the number of subjects that could be analyzed.'}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Active tDCS and Fluency Training', 'description': 'Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days).\n\nAnodal tDCS: 20 minutes of 2mA anodal stimulation.\n\nFluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham tDCS and Fluency Training', 'description': 'Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days).\n\nFluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes\n\nSham tDCS: For sham stimulation, current is ramped up and back down over 30 seconds.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scalp pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tingling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Warm sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleepiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trouble concentrating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute mood change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Changes in visual sensations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Brain Activation as Assessed by fMRI Images', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS and Fluency Training', 'description': 'Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days).\n\nAnodal tDCS: 20 minutes of 2mA anodal stimulation.\n\nFluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes'}, {'id': 'OG001', 'title': 'Sham tDCS and Fluency Training', 'description': 'Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days).\n\nFluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes\n\nSham tDCS: For sham stimulation, current is ramped up and back down over 30 seconds.'}], 'classes': [{'title': 'left supplementary motor area (SMA) (post-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.39', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'left SMA (fol-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.54', 'groupId': 'OG001'}]}]}, {'title': 'right SMA (post-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.45', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'right SMA (fol-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.35', 'groupId': 'OG001'}]}]}, {'title': 'left superior temporal gyrus (STG) (post-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.43', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'left STG (fol-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'right STG (post-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '1.56', 'spread': '1.39', 'groupId': 'OG001'}]}]}, {'title': 'right STG (fol-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '1.17', 'groupId': 'OG001'}]}]}, {'title': 'left putamen (post-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.37', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'left putamen (fol-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.42', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'right putamen (post-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.01', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'right putamen (fol-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.89', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'left inferior frontal gyrus (IFG) (post-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'left IFG (fol-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'right IFG (post-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': 'right IFG (fol-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'left premotor cortex (PMC) (post-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.33', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '1.67', 'groupId': 'OG001'}]}]}, {'title': 'left PMC (fol-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '1.11', 'groupId': 'OG001'}]}]}, {'title': 'right PMC (post-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.93', 'groupId': 'OG001'}]}]}, {'title': 'right PMC (fol-pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.32', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '1.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'familywise error rate (FWE) corrected to .05 with cluster threshold of 80 voxels.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 week (post), 4 weeks (follow up)', 'description': 'Investigators will use the fMRI images taken from before and after tDCS to determine if the treatment intervention contributed to any changes within brain regions associated with speech production. This will be measured by Blood-Oxygen-Level-Dependent (BOLD) signal change (arbitrary units). Images from scans are preprocessed. Changes in BOLD signal are modeled for contrasts within a group for \\[post-pre\\] and \\[follow up-pre\\] (e.g., active group reading condition post visit MINUS active group reading pre visit). Results are reported for reading condition.', 'unitOfMeasure': 'Percent signal change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject assigned to the sham condition did not want to participate in the MRI but participated in every other aspect of the study. Additionally, 2 subjects assigned to active and 1 assigned to sham did not complete follow up MRI due to pandemic research pause. The MRI data from one subject in the active arm was corrupted and therefore not analyzable and was excluded from MRI results. Therefore \\[post-pre\\] includes 11 active and 10 sham, whereas \\[follow up-pre\\] includes 9 active and 9 sham.'}, {'type': 'PRIMARY', 'title': 'Change in Percentage of Stuttered Syllables Produced During Speech Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS and Fluency Training', 'description': 'Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days).\n\nAnodal tDCS: 20 minutes of 2mA anodal stimulation.\n\nFluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes'}, {'id': 'OG001', 'title': 'Sham tDCS and Fluency Training', 'description': 'Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days).\n\nFluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes\n\nSham tDCS: For sham stimulation, current is ramped up and back down over 30 seconds.'}], 'classes': [{'title': '% Change post', 'categories': [{'measurements': [{'value': '-1.82', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '2.02', 'groupId': 'OG001'}]}]}, {'title': '% Change follow up', 'categories': [{'measurements': [{'value': '-1.03', 'spread': '4.17', 'groupId': 'OG000'}, {'value': '3.46', 'spread': '5.47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.936', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Interaction between visit and group.', 'groupDescription': 'Analyses conduced with a mixed ANOVA, with between-subjects factor of group (active, sham) and two within-subjects factors: time (post, follow up) and speech task (reading, conversation).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 week (post), 4 weeks (follow up)', 'description': 'Investigators will calculate the percentage of stuttered syllables (out of total syllables) in a speech sample. Decreased stuttered syllables represents better outcomes (greater reduction in stuttering).', 'unitOfMeasure': 'percent change in stuttered syllables', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline on the Overall Assessment of Speakers Experience of Stuttering (OASES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS and Fluency Training', 'description': 'Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days).\n\nAnodal tDCS: 20 minutes of 2mA anodal stimulation.\n\nFluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes'}, {'id': 'OG001', 'title': 'Sham tDCS and Fluency Training', 'description': 'Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days).\n\nFluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes\n\nSham tDCS: For sham stimulation, current is ramped up and back down over 30 seconds.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '2.48', 'spread': '.61', 'groupId': 'OG000'}, {'value': '2.67', 'spread': '.75', 'groupId': 'OG001'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '2.34', 'spread': '.55', 'groupId': 'OG000'}, {'value': '2.56', 'spread': '.78', 'groupId': 'OG001'}]}]}, {'title': 'Follow up', 'categories': [{'measurements': [{'value': '2.35', 'spread': '.57', 'groupId': 'OG000'}, {'value': '2.59', 'spread': '.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.619', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Interaction between visit and group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 week (post), 4 weeks (follow up)', 'description': "The OASES is a standardized assessment of the functional impact of stuttering on a person's life. There are 4 sub-tests: general information about speech, your reactions to stuttering, communication in daily situations, quality of life. Each one has a score from 1 to 5 with regard to impact (1 least, 5 most negative impact). These are combined to give a total impact score between 1 and 5, with 5 representing the highest negative impact on person's life. The change on the total impact score will be used. Changes are shown in the table below by comparison between the measurements at the three points in time.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline on Rhythm Judgement Task', 'timeFrame': 'Baseline, 1 week, 4 weeks', 'description': 'Investigators will compare performance accuracy on a computerized rhythm judgement task from before and after tDCS to assess effects of tDCS. Improved accuracy reflects better performance.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline on Tapping Tasks', 'timeFrame': 'Baseline, 1 week, 4 weeks', 'description': 'Investigators will compare performance on computerized tapping tasks from before and after tDCS to assess effects of tDCS.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline on Self-rated Measure of Speech Fluency', 'timeFrame': 'Baseline, 1 week, 4 weeks', 'description': 'Investigators will compare participant scores on a self-rated measure of speech fluency (1 = NO STUTTERING; 9 = EXTREMELY SEVERE STUTTERING) from before and after tDCS to assess effects of tDCS. Lower scores indicate improvement.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active tDCS and Fluency Training', 'description': 'Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days).\n\nAnodal tDCS: 20 minutes of 2mA anodal stimulation.\n\nFluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes'}, {'id': 'FG001', 'title': 'Sham tDCS and Fluency Training', 'description': 'Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days).\n\nFluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes\n\nSham tDCS: For sham stimulation, current is ramped up and back down over 30 seconds.'}], 'periods': [{'title': 'Randomized', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Received First tDCS Session', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Received Final tDCS Session', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Completed Study Follow up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Could not complete study due to COVID-19 research pause', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Participants were required to meet a certain stuttering severity status. Four participants who were enrolled did not meet the pre-assignment criteria and were thus not assigned to an arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active tDCS and Fluency Training', 'description': 'Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days).\n\nAnodal tDCS: 20 minutes of 2mA anodal stimulation.\n\nFluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes'}, {'id': 'BG001', 'title': 'Sham tDCS and Fluency Training', 'description': 'Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days).\n\nFluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes\n\nSham tDCS: For sham stimulation, current is ramped up and back down over 30 seconds.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.43', 'spread': '8.14', 'groupId': 'BG000'}, {'value': '23.31', 'spread': '2.87', 'groupId': 'BG001'}, {'value': '25.46', 'spread': '6.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stuttering Severity', 'classes': [{'categories': [{'measurements': [{'value': '5.66', 'spread': '3.23', 'groupId': 'BG000'}, {'value': '9.72', 'spread': '8.88', 'groupId': 'BG001'}, {'value': '7.69', 'spread': '6.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Investigators will calculate the percentage of stuttered syllables (out of total syllables) in a speech sample. Decreased stuttered syllables represents better outcomes (greater reduction in stuttering).', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Overall Assessment of Speaker's Experience of Stuttering", 'classes': [{'categories': [{'measurements': [{'value': '2.48', 'spread': '0.58', 'groupId': 'BG000'}, {'value': '2.67', 'spread': '0.68', 'groupId': 'BG001'}, {'value': '2.57', 'spread': '0.64', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The OASES is a standardized assessment of the functional impact of stuttering on a person's life. There are 4 sub-tests: general information about speech, your reactions to stuttering, communication in daily situations, quality of life. Each one has a score from 1 to 5 with regard to impact (1 least, 5 most negative impact). These are combined to give a total impact score between 1 and 5, with 5 representing the highest negative impact on person's life. The change on the total impact score will be used.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Includes all participants who were assigned to an arm and received the first intervention'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-25', 'size': 840403, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-29T10:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'A researcher who is not involved in any aspect of the study will randomize participants into the sham and active study arms using a minimization procedure. Allocation concealment will be achieved by assigning a unique 6-digit random code per participant, which will be provided to the researcher. The code is used to deliver stimulation. The participants and the researchers who deliver stimulation, assess outcomes, and analyze data will be masked to trial arm.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'whyStopped': 'Covid-19 paused human subjects research at study site, funding expired.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-28', 'studyFirstSubmitDate': '2018-02-12', 'resultsFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2018-02-12', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-28', 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes From Baseline on Rhythm Judgement Task', 'timeFrame': 'Baseline, 1 week, 4 weeks', 'description': 'Investigators will compare performance accuracy on a computerized rhythm judgement task from before and after tDCS to assess effects of tDCS. Improved accuracy reflects better performance.'}, {'measure': 'Changes From Baseline on Tapping Tasks', 'timeFrame': 'Baseline, 1 week, 4 weeks', 'description': 'Investigators will compare performance on computerized tapping tasks from before and after tDCS to assess effects of tDCS.'}, {'measure': 'Changes From Baseline on Self-rated Measure of Speech Fluency', 'timeFrame': 'Baseline, 1 week, 4 weeks', 'description': 'Investigators will compare participant scores on a self-rated measure of speech fluency (1 = NO STUTTERING; 9 = EXTREMELY SEVERE STUTTERING) from before and after tDCS to assess effects of tDCS. Lower scores indicate improvement.'}], 'primaryOutcomes': [{'measure': 'Changes in Brain Activation as Assessed by fMRI Images', 'timeFrame': 'Baseline, 1 week (post), 4 weeks (follow up)', 'description': 'Investigators will use the fMRI images taken from before and after tDCS to determine if the treatment intervention contributed to any changes within brain regions associated with speech production. This will be measured by Blood-Oxygen-Level-Dependent (BOLD) signal change (arbitrary units). Images from scans are preprocessed. Changes in BOLD signal are modeled for contrasts within a group for \\[post-pre\\] and \\[follow up-pre\\] (e.g., active group reading condition post visit MINUS active group reading pre visit). Results are reported for reading condition.'}, {'measure': 'Change in Percentage of Stuttered Syllables Produced During Speech Sample', 'timeFrame': 'Baseline, 1 week (post), 4 weeks (follow up)', 'description': 'Investigators will calculate the percentage of stuttered syllables (out of total syllables) in a speech sample. Decreased stuttered syllables represents better outcomes (greater reduction in stuttering).'}], 'secondaryOutcomes': [{'measure': 'Changes From Baseline on the Overall Assessment of Speakers Experience of Stuttering (OASES)', 'timeFrame': 'Baseline, 1 week (post), 4 weeks (follow up)', 'description': "The OASES is a standardized assessment of the functional impact of stuttering on a person's life. There are 4 sub-tests: general information about speech, your reactions to stuttering, communication in daily situations, quality of life. Each one has a score from 1 to 5 with regard to impact (1 least, 5 most negative impact). These are combined to give a total impact score between 1 and 5, with 5 representing the highest negative impact on person's life. The change on the total impact score will be used. Changes are shown in the table below by comparison between the measurements at the three points in time."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['transcranial direct current stimulation', 'MRI', 'Speech', 'fluency', 'tDCS'], 'conditions': ['Stuttering, Developmental']}, 'descriptionModule': {'briefSummary': 'Research studies in stuttering have shown that activity patterns in certain brain areas differ in people who stutter compared to people who do not stutter when speaking. The purpose of this study is to investigate how mild, non-invasive brain stimulation applied consecutively for five days affects speech relevant brain areas, which may in turn affect speech fluency and speaking-related brain activity in people who stutter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* history of persistent developmental stuttering\n* stuttering severity ranging from mild to very severe, specifically Stuttering Severity Instrument (SSI) total score of 20 (mild) or higher and stuttering rates of 3% or higher\n* scores within 1 standard deviation of the norm on the standardized tests for the study\n\nExclusion Criteria:\n\n* received any treatment for stuttering within the past year\n* other neurological conditions such as Tourette's syndrome or post-traumatic stress disorder\n* taking any medications/drugs that affect brain function\n* history of past or current mental illness for example, schizophrenia that may affect brain development and function\n* history of serious medical or neurological illness such as epilepsy and Parkinson's disease\n* history of closed head injury (e.g., concussion)\n* history of reading disorders\n* hearing loss\n* taking any medication, prescription or non-prescription with any psychotropic effects at the time of the study\n* metal or electronic implants such as cochlear implants, and pacemakers"}, 'identificationModule': {'nctId': 'NCT03437512', 'briefTitle': 'Non-invasive Brain Stimulation in Adults Who Stutter', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Non-invasive Brain Stimulation in Adults Who Stutter', 'orgStudyIdInfo': {'id': 'HUM00134495'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active tDCS and fluency training', 'description': 'Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days).', 'interventionNames': ['Device: Anodal tDCS', 'Behavioral: Fluency training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS and fluency training', 'description': 'Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days).', 'interventionNames': ['Behavioral: Fluency training', 'Device: Sham tDCS']}], 'interventions': [{'name': 'Anodal tDCS', 'type': 'DEVICE', 'description': '20 minutes of 2mA anodal stimulation.', 'armGroupLabels': ['Active tDCS and fluency training']}, {'name': 'Fluency training', 'type': 'BEHAVIORAL', 'description': 'Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes', 'armGroupLabels': ['Active tDCS and fluency training', 'Sham tDCS and fluency training']}, {'name': 'Sham tDCS', 'type': 'DEVICE', 'description': 'For sham stimulation, current is ramped up and back down over 30 seconds.', 'armGroupLabels': ['Sham tDCS and fluency training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Emily O Garnett, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Investigator', 'investigatorFullName': "Emily O'Dell Garnett", 'investigatorAffiliation': 'University of Michigan'}}}}