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Trial record 1 of 1 for:    202101546
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Accelerated Neuromodulation to Alleviate Cognitive Deficits Due to Cancer Therapy

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ClinicalTrials.gov Identifier: NCT04966520
Recruitment Status : Recruiting
First Posted : July 19, 2021
Last Update Posted : September 6, 2022
American Cancer Society-Holden Comprehensive Cancer Society
Fraternal Order of Eagles (Iowa)
Information provided by (Responsible Party):
Kanchna Ramchandran, University of Iowa

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).

Condition or disease Intervention/treatment Phase
Cancer Other: Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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, 2023
Estimated Study Completion Date : September 30, 2023

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

  2. 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.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

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

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Contact: Kanchna Ramchandran, MS, PHD +1 319 356-0535 kanchna-ramchandran@uiowa.edu

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United States, Iowa
University of Iowa Hospitals & Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Kanchna Ramchandran, MS, PHD    319-356-0535    kanchna-ramchandran@uiowa.edu   
Sponsors and Collaborators
Kanchna Ramchandran
American Cancer Society-Holden Comprehensive Cancer Society
Fraternal Order of Eagles (Iowa)
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Principal Investigator: Kanchna Ramchandran, MS, PHD University of Iowa Hospitals & Clinics
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Responsible Party: Kanchna Ramchandran, Associate Research Scientist, University of Iowa
ClinicalTrials.gov Identifier: NCT04966520    
Other Study ID Numbers: 202101546
First Posted: July 19, 2021    Key Record Dates
Last Update Posted: September 6, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kanchna Ramchandran, University of Iowa:
Additional relevant MeSH terms:
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Cognition Disorders
Cognitive Dysfunction
Neurocognitive Disorders
Mental Disorders