Feasibility and Tolerability of Transcranial Direct Current Stimulation With Concurrent Cognitive Training

NCT ID: NCT02726763

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-30
• Study Completion Date: 2026-03-31

Brief Summary

In this study, the investigators are testing transcranial direct current stimulation (tDCS) in breast cancer survivors. In this pilot study, the investigators want to learn if it is feasible to use this device in memory rehabilitation.

Conditions

Breast Cancer Survivors

Study Design

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

Study Groups

tDCS with cognitive training

We will collect: 1) self-reported demographic information (\~5 min) 2) cognitive functioning data (PAOFI) at session 1 and session 4 (\~10min) \[60\]; 3) behavioral data and EEG data from the tDCS stimulation task for each session (downloaded by investigators); 4) patient feedback on their experience with tDCS (tDCS Patient Experience Questionnaire (tPEQ)) for each session (\~5 min); 5) tDCS accrual and session completion rates at the completion of treatment and 6) Brunoni Adverse Events Questionnaire (\~5 min)

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

Questionnaires

Intervention Type: BEHAVIORAL

Interventions

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

Questionnaires

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Breast cancer survivors treated with chemotherapy between 40 and 65 years of age with no evidence of disease with treatment completed at least six months prior to study participation with or without current endocrine therapy.
• Self-reported new onset since initiation of treatment cognitive dysfunction as determined by telephone screen using the brief (3 questions) assessment established by Ercoli et al. [3] (endorsement on all three questions):

1. Do you think or feel that your memory or mental ability has gotten worse since you completed your breast cancer treatment?

2. Do you think that your mind isn't as sharp now as it was before your breast cancer treatments?

3. Do you feel like these problems have made it harder to function on your job or take care of things around the home?

• In the judgment of the investigators and/or consenting professional, able to read and comprehend English
• In the judgment of the consenting professional cognitively able to provide informed consent

Exclusion Criteria

• Patients with prior history of primary Central Nervous System (CNS) cancer or CNS metastases
• As per self report and/or medical record history of diagnosed neurological illness including seizure disorder, a dementing condition, or other neurological illness (multiple sclerosis, history of cerebrovascular accident, etc.)
• Participants with untreated depression or anxiety as assessed by self-report and review of medical history;
• Participants with a history of treated or untreated schizophrenia or bipolar disorder as assessed by self report and review of medical history;
• As per self report participants who are pregnant or who are breastfeeding
• As per self report participants with pacemakers, intracranial electrodes, implanted defibrillators or any other prosthesis.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Root, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

16-034

Identifier Type: -

Identifier Source: org_study_id