Cognitive training and brain stimulation for women with cognitive issues after breast cancer treatment
Neuromodulation Through Brain Stimulation-assisted Cognitive Training in Patients With Post-chemotherapy Cognitive Impairment
This study is testing if a combination of brain stimulation and cognitive training can help women who have memory problems after breast cancer treatment feel better and think more clearly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | University Medicine Greifswald Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Greifswald) |
| Trial ID | NCT04817566 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of high-definition transcranial direct current stimulation (tDCS) combined with intensive cognitive training on women experiencing cognitive impairment after chemotherapy for breast cancer. Participants will undergo a three-week program that includes cognitive training sessions alongside tDCS application, with a control group receiving sham stimulation for comparison. The study aims to assess improvements in cognitive performance, quality of life, and sleep data before, during, and after the intervention, with follow-up assessments planned to evaluate long-term effects. The findings could provide insights into the efficacy of this combined approach for enhancing cognitive function in affected individuals.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-65 who are at least six months post-chemotherapy for breast cancer and have self-reported cognitive concerns.
Not a fit: Patients with a history of dementia, severe neurological disorders, or contraindications to tDCS may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cognitive function and quality of life for women suffering from post-chemotherapy cognitive impairment.
How similar studies have performed: Preliminary studies have shown positive effects of cognitive training, but combining it with tDCS is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Chemotherapy to treat breast cancer (≥ 6 months post-treatment). 2. Self-reported concerns regarding cognitive functioning. 3. Age: 18-65 years. 4. right-handedness Exclusion Criteria: 1. History of dementia before treatment of cancer. 2. Other neurodegenerative neurological disorders; epilepsy or history of seizures. 3. Severe and untreated medical conditions that preclude participation in the training, as determined by responsible physician. 4. History of moderate to severe substance use disorder according to DSM-5 5. Moderate to severe acute psychiatric disorders according to DSM-5 6. Contraindication to tDCS application (Antal et al., 2017)
Where this trial is running
Greifswald
- University Medicine Greifswald — Greifswald, Germany (Recruiting)
Study contacts
- Study coordinator: Agnes Flöel, Prof.
- Email: agnes.floeel@med.uni-greifswald.de
- Phone: 0049 3834 86 6815
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.