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| Name | Class |
|---|---|
| American Cancer Society-Holden Comprehensive Cancer Society | UNKNOWN |
| Fraternal Order of Eagles (Iowa) | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) or sham | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean changes in executive cognitive function between pre and post application of iTBS treatment protocol | 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. | 1.5 months |
| Mean changes in brain metabolite concentrations between pre and post application of iTBS treatment protocol | 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. | 1.5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sneha Phadke, DO | University of Iowa Hospitals & Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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