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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Mean changes in executive cognitive function between pre and post application of iTBS treatment protocol
Study Overview
Brief Summary
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).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) or sham
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).
Intervention: Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) (Other)
Outcomes
Primary Outcomes
Mean changes in executive cognitive function between pre and post application of iTBS treatment protocol
Time Frame: 1.5 months
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.
Mean changes in brain metabolite concentrations between pre and post application of iTBS treatment protocol
Time Frame: 1.5 months
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Sneha Phadke
Clinical Associate Professor
University of Iowa