Accelerated Neuromodulation to Alleviate Cognitive Deficits Due to Cancer Therapy

NCT ID: NCT04966520

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2026-01-21

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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society-Holden Comprehensive Cancer Society

UNKNOWN

Sponsor Role: collaborator

Fraternal Order of Eagles (Iowa)

UNKNOWN

Sponsor Role: collaborator

Sneha Phadke

OTHER

Sponsor Role: lead

Responsible Party

Sneha Phadke

Clinical Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sneha Phadke, DO

Role: PRINCIPAL_INVESTIGATOR

University of Iowa Hospitals & Clinics

Locations

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

202101546

Identifier Type: -

Identifier Source: org_study_id