Accelerated Neuromodulation to Alleviate Cognitive Deficits Due to Cancer Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04966520|
Recruitment Status : Recruiting
First Posted : July 19, 2021
Last Update Posted : July 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Other: Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||September 30, 2022|
Experimental: 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).
Other: Accelerated 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04966520
|Contact: Kanchna Ramchandran, MS, PHD||+1 319 email@example.com|
|United States, Iowa|
|University of Iowa Hospitals & Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Kanchna Ramchandran, MS, PHD 319-356-0535 firstname.lastname@example.org|
|Principal Investigator:||Kanchna Ramchandran, MS, PHD||University of Iowa Hospitals & Clinics|