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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer Survivors

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation (tDCS)
* Behavioral: Questionnaires


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS with cognitive training<br>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)<br> <br> Behavioral: Questionnaires<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of subjects recruited | feasibility defined by the number of subjects recruited in a six month time frame | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Direct Current Stimulation (tDCS), Cognitive Training, 16-034