tDCS + Cognitive Training for Breast Cancer Survivors

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: CNS cancer, Neurological illness, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a device called transcranial direct current stimulation (tDCS) can improve memory in breast cancer survivors. The focus is on those who have experienced memory issues since completing chemotherapy. Participants will undergo cognitive training combined with tDCS to assess its effectiveness. Ideal candidates are breast cancer survivors who completed chemotherapy at least six months ago and are experiencing new memory problems. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance memory recovery strategies for breast cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators.

What prior data suggests that this device is safe for memory rehabilitation in breast cancer survivors?

Research shows that transcranial direct current stimulation (tDCS) is generally safe and easy to tolerate. Studies have found that tDCS is painless and simple to use. It has helped with attention problems and improved thinking skills in cancer survivors. Most people experience only mild side effects, if any, providing strong evidence that this treatment is safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial direct current stimulation (tDCS) combined with cognitive training for breast cancer survivors because it offers a non-invasive approach to potentially improve cognitive function, which can be affected by cancer treatments. Unlike traditional therapies that may focus on medication or surgery, tDCS uses gentle electrical currents to stimulate specific areas of the brain, which might enhance cognitive performance without the side effects associated with drugs. This technique also allows for targeted brain modulation, possibly leading to more personalized and effective cognitive rehabilitation.

What evidence suggests that tDCS is effective for memory rehabilitation in breast cancer survivors?

Research has shown that transcranial direct current stimulation (tDCS), which participants in this trial will receive alongside cognitive training, might improve thinking and memory in breast cancer survivors. Studies have found that tDCS is easy and comfortable for patients to use. It may also help with attention and memory issues. Some evidence suggests that when combined with brain exercises, tDCS could enhance skills like remembering words, holding information in mind, and thinking quickly. Although more research is needed, early results are promising for those experiencing cognitive issues related to cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

James Root, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors aged 40-65 who finished chemotherapy at least six months ago, have no current evidence of disease, and may or may not be on endocrine therapy. They should self-report memory or cognitive issues post-treatment and must understand English. Excluded are those with pacemakers, neurological illnesses, pregnancy/breastfeeding status, schizophrenia, bipolar disorder, untreated depression/anxiety, or a history of CNS cancer.

Inclusion Criteria

In the judgment of the investigators and/or consenting professional, able to read and comprehend English

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.

I am a breast cancer survivor, aged 40-65, treated with chemotherapy, disease-free for at least 6 months.

Exclusion Criteria

I have depression or anxiety that hasn't been treated.

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.)

I have had brain cancer or cancer that spread to my brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial direct current stimulation (tDCS) with concurrent cognitive training

6 months

4 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Questionnaires
• tDCS

Trial Overview

The study tests the feasibility of using transcranial direct current stimulation (tDCS) alongside cognitive training to help improve memory in breast cancer survivors. It's a pilot study aimed at determining if this approach can be part of memory rehabilitation.

How Is the Trial Designed?

Group I: tDCS with cognitive training Experimental Treatment 2 Interventions

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)

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) significantly reduced negative affect in overnight abstinent smokers, as evidenced by lower scores on the Profile of Mood States (POMS) after real tDCS compared to sham stimulation.

While tDCS showed promise in improving mood, it did not significantly affect cigarette craving or attention, indicating that while it is safe and may help with negative emotions, its overall efficacy in treating tobacco dependence needs further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation reduces negative affect but not cigarette craving in overnight abstinent smokers. Xu, J., Fregni, F., Brody, AL., et al.[2021]

The study aims to evaluate the effectiveness of combining cognitive behavioral therapy (CBT) with transcranial direct current stimulation (tDCS) in treating Major Depressive Disorder (MDD) in 192 patients, with assessments at multiple time points over 30 weeks.

This trial will not only measure changes in depression scores but also explore the neurobiological effects of the combined treatment using neuropsychological tests and fMRI, potentially providing insights into how these interventions work together to improve brain function in MDD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PsychotherapyPlus: augmentation of cognitive behavioral therapy (CBT) with prefrontal transcranial direct current stimulation (tDCS) in major depressive disorder-study design and methodology of a multicenter double-blind randomized placebo-controlled trial. Bajbouj, M., Aust, S., Spies, J., et al.[2022]

Transcranial direct current stimulation (tDCS) applied to the left prefrontal cortex significantly improved verbal working memory and naming abilities in healthy adults, with effects lasting for 2 weeks after stimulation.

tDCS targeting the right prefrontal cortex enhanced visuospatial working memory, indicating that different areas of the prefrontal cortex can be stimulated for specific cognitive improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of the working memory and naming by transcranial direct current stimulation. Jeon, SY., Han, SJ.[2022]

Transcranial direct current stimulation (tDCS) is a safe and affordable neuromodulatory technique that shows potential for modulating cognitive functioning, particularly in longitudinal studies where repeated sessions are used.

While tDCS has demonstrated some cognitive benefits, the effects are less consistent compared to its impact on motor outcomes, and more research is needed to understand the mechanisms behind its efficacy and to identify which individuals respond best to the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Effects of Transcranial Direct Current Stimulation in Healthy and Clinical Populations: An Overview. Berryhill, ME., Martin, D.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7446233/

Impact of transcranial direct current stimulation on ...

Results suggest that tDCS is feasible, tolerable, and may be an effective intervention to improve sustained attention difficulties in survivors with cancer- ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07112521?cond=cancer&aggFilters=status%3Arec

tDCS Intervention in Breast Cancer Survivors With and ...

This study aims to (1) evaluate the effectiveness of home-based tDCS in improving cognitive function in BC survivors and (2) examine obesity as ...

3.

bmjopen.bmj.com

bmjopen.bmj.com/content/15/5/e096162

Neuromodulation through brain stimulation-assisted ...

The evidence suggests that cognitive training may improve subjective cognitive function, processing speed, verbal memory, working memory and episodic memory in ...

4.

scholars.mssm.edu

scholars.mssm.edu/en/publications/impact-of-transcranial-direct-current-stimulation-on-sustained-at-2

Impact of transcranial direct current stimulation on sustained ...

Conclusions: Results suggest that tDCS is feasible, tolerable, and may be an effective intervention to improve sustained attention difficulties ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07112521

NCT07112521 | tDCS Intervention in Breast Cancer Survivors ...

The goal of this intervention is to investigate whether transcranial Direct Current Stimulation (tDCS) can alleviate Cancer-Related Cognitive Impairment ...

6.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2837962

Personalized Transcranial Direct Current Stimulation for ...

Findings In this comparative effectiveness study in 16 participants, individualized tDCS was associated with significantly greater improvements ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11032211/

The Application of tDCS to Treat Pain and Psychocognitive ...

Overall, the results suggest that tDCS has shown efficacy in relieving pain, reducing anxiety and depression, and improving cognitive function ...