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

Breast Cancer Survivors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02726763
• Other study ID #: 16-034
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 30, 2016
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Survivors

Intervention

Device:
• Transcranial Direct Current Stimulation (tDCS)

Behavioral:
• Questionnaires

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of subjects recruited	feasibility defined by the number of subjects recruited in a six month time frame	6 months

External Links

•   Memorial Sloan Kettering Cancer Center