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

18 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a device called transcranial direct current stimulation (tDCS) on breast cancer survivors. tDCS uses a small electrical current to stimulate the brain. The goal is to see if this can help improve memory in these patients.

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 data supports the effectiveness of this treatment?

Research shows that transcranial direct current stimulation (tDCS) can improve cognitive functions like working memory and attention in people with schizophrenia and healthy individuals. This suggests that tDCS might help improve cognitive abilities in breast cancer survivors as well. ^{1 2 3 4 5}

Is tDCS safe for humans?

Transcranial Direct Current Stimulation (tDCS) is generally considered safe for humans, with most studies reporting only mild side effects like tingling or itching at the site of stimulation. It has been used in research for various conditions, and no serious adverse effects have been commonly reported. ^{6 7 8 9 10}

How does the treatment tDCS differ from other treatments for breast cancer survivors?

tDCS (Transcranial Direct Current Stimulation) is unique because it is a non-invasive treatment that uses a mild electrical current to stimulate specific areas of the brain, potentially improving cognitive function. Unlike traditional drug treatments, tDCS is applied directly to the scalp and is considered safe and well-tolerated, with potential benefits seen in repeated sessions. ^{1 2 4 5 11}

Research Team

James Root, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of transcranial direct current stimulation (tDCS) on cognition, symptoms, and smoking in schizophrenia: A randomized controlled study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Cognitive Effects of Transcranial Direct Current Stimulation in Healthy and Clinical Populations: An Overview. [2019]

3. Germany 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. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Mood and cognitive function following repeated transcranial direct current stimulation in healthy volunteers: a preliminary report. [2013]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Improvement of the working memory and naming by transcranial direct current stimulation. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Very Late Treatment-Related Alterations in Brain Function of Breast Cancer Survivors. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Cognitive dysfunction and symptom burden in women treated for breast cancer: a prospective behavioral and fMRI analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Multivariate pattern analysis of FMRI in breast cancer survivors and healthy women. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Prospective evaluation of functional brain activity and oxidative damage in breast cancer: changes in task-induced deactivation during a working memory task. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Cross-Sectional Characterization of Local Brain Network Connectivity Pre and Post Breast Cancer Treatment and Distinct Association With Subjective Cognitive and Psychological Function. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation reduces negative affect but not cigarette craving in overnight abstinent smokers. [2021]