Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2026-02-20 @ 10:08 PM
Study NCT ID:
NCT03606161
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2018-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Navigated Repetitive Transcranial Magnetic Stimulation in Improving Motor Rehabilitation in Participants With Brain Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2018-07-20', 'studyFirstSubmitQcDate': '2018-07-20', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Motor recovery', 'timeFrame': 'Up to 3 months', 'description': 'Will conduct a paired sample t-test, subtracting post-intervention scores from pre-intervention scores at each post-intervention time point.'}, {'measure': 'Changes in cortical activity', 'timeFrame': 'Baseline up to 3 months', 'description': 'Will include pre and post comparisons of the electroencephalogram, via event related potential (ERP) analysis. Baseline LORETA analyses will include global differences in cortical activation as well as site-specific dominant frequencies for each patient. Will observe baseline differences in amplitude, power, and relative power for delta, theta, alpha, low beta, high beta, gamma, theta/beta ratio, and alpha/beta ratios for each patient. ERP analysis will compare amplitudes in the surgical hemisphere and the normal hemisphere via an asymmetry index which will be computed for each pair of homologous electrodes and in each condition: AI = (surgical ERP) - (healthy ERP on the homologous site)/the peak ERP at any site. To assess inter-hemispheric imbalances in cortical excitability, will determine differences in the nrTMS group and the Human Brain Index Reference Database (HBIRD).'}], 'primaryOutcomes': [{'measure': 'Intervention adherence', 'timeFrame': 'Up to 3 months', 'description': 'Will be defined as a participant as completing at least 70% of the (i.e., seven out of 10) treatment sessions. Feasibility will be defined as: 1) at least 70% of the participants adhere to the treatment. Patients will have to finish all 10 trains in each navigated repetitive transcranial magnetic stimulation (nrTMS) run in order to be considered complete; 2) at least 37% of the eligible patients (at a rate of approximately 3/8 per month) enroll in the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': "This trial studies how well navigated repetitive transcranial magnetic stimulation works in improving motor rehabilitation in participants with brain tumors. Navigated repetitive transcranial magnetic stimulation may help improve patients' lost motor function after surgery.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Determine feasibility of conducting 10 sessions of navigated repetitive transcranial magnetic stimulation (nrTMS) during the post-surgical rehabilitation time period.\n\nEXPLORATORY OBJECTIVES:\n\nI. Explore the effects of the nrTMS training program on motor recovery. II. Explore changes in cortical activity: electroencephalographic (EEG) activity including event-related potentials (ERPs) and motor evoked potentials (MEPs) will be assessed from baseline to end of treatment (EOT).\n\nOUTLINE:\n\nBetween 1-7 days after standard of care surgery, participants undergo 10 nrTMS sessions over 30 minutes each over 3 weeks.\n\nAfter completion of study, participants are followed up at 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with brain tumors associated with the motor cortex\n* Understand and read English, sign a written informed consent, and be willing to follow protocol requirements\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Motor impairment must be related to the surgical procedure or the tumor itself (in the opinion of the treating physician)\n* Patients who are within 7 days of brain tumor resection associated with the motor cortex\n* Eligibility for the nrTMS treatment will be based on motor ability and will be determined postoperatively by the surgeon\n\nExclusion Criteria:\n\n* Patients who are taking any antipsychotic medications\n* Patients who have ever been diagnosed with bipolar disorder or schizophrenia\n* Patients with a history of stroke'}, 'identificationModule': {'nctId': 'NCT03606161', 'briefTitle': 'Navigated Repetitive Transcranial Magnetic Stimulation in Improving Motor Rehabilitation in Participants With Brain Tumors', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Feasibility of Navigated Repetitive Transcranial Magnetic Stimulation (nrTMS) to Augment the Effects of Motor Rehabilitation in Brain Tumor Patients', 'orgStudyIdInfo': {'id': '2018-0269'}, 'secondaryIdInfos': [{'id': 'NCI-2018-01476', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2018-0269', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive care (nrTMS)', 'description': 'Between 1-7 days after standard of care surgery, participants undergo 10 nrTMS sessions over 30 minutes each over 3 weeks.', 'interventionNames': ['Other: Questionnaire Administration', 'Procedure: Transcranial Magnetic Stimulation']}], 'interventions': [{'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (nrTMS)']}, {'name': 'Transcranial Magnetic Stimulation', 'type': 'PROCEDURE', 'otherNames': ['TMS'], 'description': 'Undergo nrTMS', 'armGroupLabels': ['Supportive care (nrTMS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Sarah Prinsloo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}