Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT04966520
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-10
First Post:
2021-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Accelerated Neuromodulation to Alleviate Cognitive Deficits Due to Cancer Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-01-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2021-06-10', 'studyFirstSubmitQcDate': '2021-07-14', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean changes in executive cognitive function between pre and post application of iTBS treatment protocol', 'timeFrame': '1.5 months', 'description': 'Executive cognitive function will be quantified using technician administered Color Word Interference Test, Category Fluency, Tower of Hanoi, Card Sort and Strategy Application Task (Shallice \\&Burgess) tests, and the self-report Functional Assessment of Cancer Therapy - Cognitive Scale (FACT-COG) (Dyk et al.). Executive Function (EF) is measured by utilizing standardized test scores adapted from the Delis-Kaplan Executive Function Scales (D-KEFS battery) (Homack et al.). FACT-COG, Category Fluency and Strategy Application Task use raw scores. All EF measures used in this battery form a part of a normative database created and maintained by the principle investigator of this study. An overall score of EF is computed by averaging the Z scores of each test. Higher score on each test represents better performance.'}, {'measure': 'Mean changes in brain metabolite concentrations between pre and post application of iTBS treatment protocol', 'timeFrame': '1.5 months', 'description': 'Proton Magnetic Resonance Spectroscopy will be used to quantify brain metabolite concentrations in parts per million. Brain metabolites under evaluation include: glutamine, glutamate, N-acetyl aspartate, choline, and creatine.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neuromodulation', 'chemo-brain'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'This project is aimed at the discovery of neuro-modulation techniques that may alleviate chemotherapy induced cognitive deficits (CICD), especially in executive (higher-order) cognitive function (EF).', 'detailedDescription': 'The specific aim for this study is to use magnetic resonance spectroscopy (MRS), self-report, and neuropsychological testing to identify changes in brain metabolite concentrations/ratios and changes in EF deficits associated with chemotherapy, before and after accelerated theta-burst transcranial stimulation (iTBS). The secondary aim is to assess for any association of changes in executive function with brain metabolite concentrations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women or men with a history of non-metastatic cancer who have completed definitive curative cancer therapy\n* Received cytotoxic chemotherapy as a part of their therapy for cancer and at least one month has passed since the final cytotoxic chemotherapy treatment\n* ≥ 18 years of age at time of cancer diagnosis and receipt of chemotherapy\n* Patients must report subjective symptoms of "chemo-brain" (memory loss, difficulty with concentration, word-finding difficulties) with a FACT-Cog perceived cognitive impairment score \\< 60\n* Ability to sign informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* Patients with a recurrence of cancer or those with current metastatic disease\n* Patients with a history or current diagnosis of brain metastasis\n* Patients with a history or current diagnosis of a primary brain tumor\n* Patients with a history of brain surgery or brain radiation\n* Patients receiving maintenance systemic therapy for cancer, other than endocrine therapy\n* Patients who cannot produce or request adequate medical record documentation to ensure they meet inclusion and exclusion criteria\n* Women who are currently pregnant\n* History of childhood cancer or receipt of chemotherapy in childhood (\\<age 18). Developmental insult to the PFC, can be associated with long-term, durable and sometime debilitating cognitive deficits. Hence, we avoid any cognitive confounds that maybe related to this issue.\n* Patients with a weight over 250 lbs., as these patients would not fit in the MRI scanner used in the protocol\n* Patients who require benzodiazepines for MRI due to claustrophobic anxiety\n* Patients with chest wall tissue expanders or other retained 7 Tesla MRI-incompatible metal. Any other specific contraindication to TMS or MRI not already listed above, including:\n* (a) any implanted device in the head, neck or upper body (e.g. cochlear implant, cranial or other electrodes, pacemaker or defibrillator, medication pump, stent, aneurysm clip, etc.)\n* (b) personal history of seizures or epilepsy, personal history of multiple concussions or unexplained loss of consciousness. This will be determined by physician judgement\n* History of adverse reaction to previous TMS or MRI exposure\n* Active substance use disorder in the past 6 months, excluding tobacco use disorder, as diagnosed by study physicians'}, 'identificationModule': {'nctId': 'NCT04966520', 'briefTitle': 'Accelerated Neuromodulation to Alleviate Cognitive Deficits Due to Cancer Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Repetitive Intermittent Accelerated Theta-burst Transcranial Stimulation(iTBS) as a Potential Intervention for Chemotherapy Induced Cognitive Deficits (CICD)- a Pilot Clinical Trial to Explore Feasibility and Efficacy', 'orgStudyIdInfo': {'id': '202101546'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) or sham', 'description': 'Patients will participate in the prospective longitudinal research protocol over a period of 1.5 months.\n\nTreatment will include 8 visits of either accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) or iTBS sham stimulation. Patients will be informed that iTBS sham stimulations will be part of the protocol (but will be blind to when treatment/sham will be administered).', 'interventionNames': ['Other: Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS)']}], 'interventions': [{'name': 'Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS)', 'type': 'OTHER', 'description': 'Accelerated iTBS will be used to stimulate the regions of interest of mPFC and L-DLPFC nodes in cancer survivors or patients.\n\nAccelerated iTBS will be administered in a single half-day period to allow for a 50minutes interval between any two treatments to minimize interference effects between treatments. Thus, there will be \\~10 minute sessions of stimulation x 2 applications per node x 2 nodes (L-DLPFC, mPFC) = 40 total minutes of daily stimulation - each session delivers 1800 pulses in a 5 Hz triplet burst frequency, 2 second trains with intertrain interval of 8 seconds; triplets occur with 50 Hz frequency, as per standard iTBS protocols for depression treatment. The treatment will be offered for five consecutive days.', 'armGroupLabels': ['Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) or sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals & Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Sneha Phadke, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa Hospitals & Clinics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sneha Phadke', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Cancer Society-Holden Comprehensive Cancer Society', 'class': 'UNKNOWN'}, {'name': 'Fraternal Order of Eagles (Iowa)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Sneha Phadke', 'investigatorAffiliation': 'University of Iowa'}}}}