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Clinical Trials/NCT02726763
NCT02726763
Active, not recruiting
Not Applicable

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

Memorial Sloan Kettering Cancer Center1 site in 1 country18 target enrollmentMarch 30, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Survivors
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
18
Locations
1
Primary Endpoint
number of subjects recruited
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 30, 2016
End Date
March 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

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):
  • 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

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.

Outcomes

Primary Outcomes

number of subjects recruited

Time Frame: 6 months

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

Study Sites (1)

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