Cancer
Conditions
Keywords
neuromodulation, chemo-brain
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.
Interventions
OTHERAccelerated repetitive intermittent theta-burst transcranial stimulation (iTBS)
Accelerated iTBS will be used to stimulate the regions of interest of mPFC and L-DLPFC nodes in cancer survivors or patients. Accelerated 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.
Sponsors
Sneha Phadke
American Cancer Society-Holden Comprehensive Cancer Society
Fraternal Order of Eagles (Iowa)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean changes in executive cognitive function between pre and post application of iTBS treatment protocol | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSneha Phadke, DO
University of Iowa Hospitals & Clinics
Outcome results
None listed