Breast Cancer SurvivorsNCT02726763
Feasibility and Tolerability of Transcranial Direct Current Stimulation With Concurrent Cognitive Training
A study testing Transcranial Direct Current Stimulation (tDCS) and Questionnaires in people with Breast Cancer Survivors, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Breast Cancer Survivors
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS) and Questionnaires
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2016to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Pilot Study of Feasibility and Tolerability of Transcranial Direct Current Stimulation With Concurrent Cognitive Training
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
- Being tested
- Transcranial Direct Current Stimulation (tDCS), Questionnaires
- Keywords
- Transcranial Direct Current Stimulation (tDCS), Cognitive Training, 16-034
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
QuestionnairesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of subjects recruited
feasibility defined by the number of subjects recruited in a six month time frame
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study start30 Mar 2016
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Root, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726763
- Sponsor's protocol ID
- 16-034
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2016
- Last updated
- 27 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Feasibility and Tolerability of Transcranial Direct Current Stimulation With Concurrent Cognitive Training
- ClinicalTrials.gov ID
- NCT02726763
- Acronym / sponsor ID
- 16-034
- Conditions
- Breast Cancer Survivors
- Keywords
- Transcranial Direct Current Stimulation (tDCS), Cognitive Training, 16-034
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 30 Mar 2016 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tDCS with cognitive training | Experimental | Device: Transcranial Direct Current Stimulation (tDCS), Behavioral: QuestionnairesWe 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) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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):
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Device | tDCS with cognitive training |
| Questionnaires | Behavioural | tDCS with cognitive training |
Primary outcome
number of subjects recruited
Time frame: 6 months
feasibility defined by the number of subjects recruited in a six month time frame
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Root, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) and Questionnaires in people with Breast Cancer Survivors, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of subjects recruited (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.