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

NCT02726763 | Active Not Recruiting

• 1 other identifier: 16-034
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Keywords

Transcranial Direct Current Stimulation (tDCS); Cognitive Training; 16-034

Outcome Measures

Primary Outcomes (1)

• number of subjects recruited

  feasibility defined by the number of subjects recruited in a six month time frame

  6 months

Study Arms (1)

tDCS with cognitive training

EXPERIMENTAL

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)

Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Questionnaires

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

tDCS with cognitive training

Questionnaires BEHAVIORAL

tDCS with cognitive training

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• Do you think or feel that your memory or mental ability has gotten worse since you completed your breast cancer treatment?
• Do you think that your mind isn't as sharp now as it was before your breast cancer treatments?
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

Transcranial Direct Current Stimulation; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• James Root, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 4, 2016
• Study Start: March 30, 2016
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)