Clinical trial · Interventional
Accelerated Neuromodulation to Alleviate Cognitive Deficits Due to Cancer Therapy
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
NCT04966520CI-TRIAL-00102947completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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. Treatment 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)
Primary outcomes (2)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Women or men with a history of non-metastatic cancer who have completed definitive curative cancer therapy * Received cytotoxic chemotherapy as a part of their therapy for cancer and at least one month has passed since the final cytotoxic chemotherapy treatment * ≥ 18 years of age at time of cancer diagnosis and receipt of chemotherapy * 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 * Ability to sign informed consent and comply with study procedures Exclusion Criteria: * Patients with a recurrence of cancer or those with current metastatic disease * Patients with a history or current diagnosis of brain metastasis * Patients with a history or current diagnosis of a primary brain tumor * Patients with a history of brain surgery or brain radiation * Patients receiving maintenance systemic therapy for cancer, other than endocrine therapy * Patients who cannot produce or request adequate medical record documentation to ensure they meet inclusion and exclusion criteria * Women who are currently pregnant * 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. * Patients with a weight over 250 lbs., as these patients would not fit in the MRI scanner used in the protocol * Patients who require benzodiazepines for MRI due to claustrophobic anxiety * 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: * (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.) * (b) personal history of seizures or epilepsy, personal history of multiple concussions or unexplained loss of consciousness. This will be determined by physician judgement * History of adverse reaction to previous TMS or MRI exposure * Active substance use disorder in the past 6 months, excluding tobacco use disorder, as diagnosed by study physicians
References
Publications (0)
Data not yet available
No reference posted for this study.