Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-29 @ 4:45 PM
Study NCT ID:
NCT05368350
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-04
First Post:
2022-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating Primary Progressive Aphasia and Apraxia of Speech Using Non-invasive Brain Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018888', 'term': 'Aphasia, Primary Progressive'}, {'id': 'D001072', 'term': 'Apraxias'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001037', 'term': 'Aphasia'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Study participants will be assigned to either Pre-SMA or LIFG arm.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-04-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2022-05-05', 'studyFirstSubmitQcDate': '2022-05-05', 'lastUpdatePostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Controlled Oral Word Association Test', 'timeFrame': 'Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.', 'description': 'Evaluation of treatment differences in change on the Control Word Association Test\n\nBenton, L.A., Hamsher, K., \\& Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.'}, {'measure': 'Category Fluency', 'timeFrame': 'Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.', 'description': 'Evaluation of treatment differences in change on Category Fluency\n\nBenton, L.A., Hamsher, K., \\& Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.'}, {'measure': 'The Boston Naming Test', 'timeFrame': 'Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.', 'description': 'Evaluation of treatment differences in change on The Boston Naming Test (accuracy and speech latency)\n\nKaplan, E., Goodglass, H., \\& Weintraub, S., (1983). Boston Naming Test (2nd ed.). Lea \\& Febiger: Philadelphia.'}, {'measure': 'Spontaneous speech (content and fluency) of the Western Aphasia Battery-Revised', 'timeFrame': 'Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.', 'description': 'Evaluation of treatment differences in change on Spontaneous speech (content and fluency) of the Western Aphasia Battery-Revised\n\nKertesz, Andrew. ( 1982). The Western aphasia battery. New York :Grune \\& Stratton.'}, {'measure': 'The Apraxia battery for Adults - 2 (ABA - 2)', 'timeFrame': 'Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.', 'description': 'Evaluation of treatment differences in change on characteristics of articulation of the the Apraxia battery for Adults - 2\n\nDabul, B. L. (2000). Apraxia Battery for Adults (ABA-2) (2nd edn). Austin, TX: ProEd.'}], 'secondaryOutcomes': [{'measure': 'The Trail Making Test (Part A & B)', 'timeFrame': 'Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.', 'description': 'Evaluation of treatment differences in change on The Trail Making Test (Part A \\& B)\n\nReitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.'}, {'measure': 'The Digit Span Forward & Backward', 'timeFrame': 'Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.', 'description': 'Evaluation of treatment differences in change on The Digit Span Forward \\& Backward\n\nWechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.'}, {'measure': 'The Digit Symbol Substitution Test', 'timeFrame': 'Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.', 'description': 'Evaluation of treatment differences in change on The Digit Symbol Substitution Test\n\nWechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.'}, {'measure': 'The Hopkins Verbal Learning Test-Revised', 'timeFrame': 'Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.', 'description': 'Evaluation of treatment differences in change on The Hopkins Verbal Learning Test-Revised\n\nBenedict, R. H. B., Schretlen, D., Groninger, L., \\& Brandt, J. (1998). The Hopkins verbal learning test-revised: Normative data and analysis of interform and test-retest reliability. Clinical Neuropsychologist, 12, 43-55.'}, {'measure': 'The Rey-Osterrieth Complex Figure Test', 'timeFrame': 'Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.', 'description': "Evaluation of treatment differences in change on The Rey-Osterrieth Complex Figure Test\n\nRey, A. (1941). L'examen psychologique dans les cas d'encéphalopathie traumatique. (Les problems.). \\[The psychological examination in cases of traumatic encepholopathy. Problems.\\]. Archives de Psychologie, 28, 215- 285."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Primary Progressive Aphasia', 'Apraxia of Speech']}, 'referencesModule': {'references': [{'pmid': '41041680', 'type': 'DERIVED', 'citation': 'Dugas CS, Chiang HS, Devora P, Lucas-Mendoza K, Abasi C, Adhikari A, Nguyen T, Frolov A, Kelley BJ, LoBue C, Mudar RA, Hart J Jr. High-definition brain stimulation targeting separate regions leads to differential word retrieval outcomes in patients with primary progressive aphasia: a pilot study. Front Neurol. 2025 Sep 17;16:1630103. doi: 10.3389/fneur.2025.1630103. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., pre-supplementary motor area and left inferior frontal gyrus) thought to aid in memory will improve speech and language difficulties in patients with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS). The primary outcome measures are neuropsychological assessments of speech and language functions, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures.', 'detailedDescription': 'This pilot study has one treatment arm with open-label treatment and will examine improvement of speech output, verbal fluency, and other cognitive deficits associated with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS), by utilizing 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to pre-supplementary motor area or left inferior frontal gyrus for 20 minutes over 10 sessions. There will be baseline testing, and follow up testing immediately after and 8 weeks after completion of treatment.\n\nAll patients with a clinical diagnosis of PPA or PAOS will be assigned to either one of the two open-label arms to receive active tDCS. Primary outcome speech and language measures, secondary neuropsychological and electroencephalography (EEG) measures, and pre-screening assessments for study medical history and contraindications for treatment will be collected prior to the treatment (i.e., baseline).\n\nPrimary outcome speech and language functions measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected after treatment session 10 and following treatment competition (i.e., 8-week).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 85 years of age\n* A formal diagnosis of primary progressive aphasia (nonfluent/agrammatic, semantic, logopenic variants or mixed) and/or progressive apraxia of speech\n* Capable of understanding and signing an informed consent. Medical information/history, as well as mental status exam and diagnosis provided by referring physician will determine whether or not a caregiver is required to be involved during this process.\n\nExclusion Criteria:\n\n* Has an implanted device, such as a pacemaker, metallic cranial implant, or a neurostimulator\n* Skull defects\n* Pregnant\n* A significant history of arrhythmia or epileptic seizures.\n* Not a native English speaker\n* Currently receiving speech-language intervention\n* Unable to communicated verbally'}, 'identificationModule': {'nctId': 'NCT05368350', 'briefTitle': 'Treating Primary Progressive Aphasia and Apraxia of Speech Using Non-invasive Brain Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas at Dallas'}, 'officialTitle': 'Treating Primary Progressive Aphasia and Apraxia of Speech With High Definition Transcranial Direct Current Stimulation (HDtDCS-PPA/PAOS)', 'orgStudyIdInfo': {'id': 'UTD IRB: 24-595'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Pre-SMA tDCS treatment', 'description': 'This open-label treatment will examine improvement of speech output, verbal fluency, and other cognitive deficits associated with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS), by utilizing 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to pre-supplementary motor area for 20 minutes over 10 sessions. There will be baseline testing, and follow up testing immediately after and 8 weeks after completion of treatment.', 'interventionNames': ['Device: high-definition transcranial direct current stimulation (HD-tDCS)']}, {'type': 'EXPERIMENTAL', 'label': 'Active LIFG tDCS treatment', 'description': 'This open-label treatment will examine improvement of speech output, verbal fluency, and other cognitive deficits associated with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS), by utilizing 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to left inferior frontal gyrus for 20 minutes over 10 sessions. There will be baseline testing, and follow up testing immediately after and 8 weeks after completion of treatment.', 'interventionNames': ['Device: high-definition transcranial direct current stimulation (HD-tDCS)']}], 'interventions': [{'name': 'high-definition transcranial direct current stimulation (HD-tDCS)', 'type': 'DEVICE', 'description': 'Other Names:\n\ntDCS\n\n1 milliamp tDCS High definition tDCS High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10 Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with (1) Pre-SMA stimulation arm -- anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns or (2) LIFG stimulation arm -- at electrode F7 (International 10/10 System for electroencephalography electrode placement) and electrodes T7, FP1, AF3, and FC5 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.', 'armGroupLabels': ['Active LIFG tDCS treatment', 'Active Pre-SMA tDCS treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'John Hart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas at Dallas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas at Dallas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'John Hart, Jr.', 'investigatorAffiliation': 'The University of Texas at Dallas'}}}}