Cognitive Training and Brain Stimulation in Women With Post-chemotherapy Cognitive Impairment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anodal tDCS, Sham tDCS, Intensive cognitive training.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Cognitive Impairment. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neuromodulation Through Brain Stimulation-assisted Cognitive Training in Patients With Post-chemotherapy Cognitive Impairment
Overview
The aim of this study is to investigate whether a high definition tDCS-accompanied intensive cognitive training of working memory leads to performance improvement in women with post-chemotherapy cognitive impairment after breast cancer treatment.
Detailed description
Patients who have undergone chemotherapy, may develop post-chemotherapy cognitive impairment (PCCI), which may occur in several cognitive domains and persist for many years. These declines in cognitive functions can lead to psychological distress and affect overall patients' quality of life. The goal of the present study is to assess behavioral effects of a multi-session cognitive training combined with high-definition transcranial direct current stimulation (tDCS) in women with PCCI. First studies have shown positive effects of cognitive training on trained and untrained functions and the subjective perception of stress, however the effects are small and transfer effects are inconsistent. A promising approach to elongate and increase the effects of cognitive training is to combine the training with tDCS. Therefore, in this study women with PCCI will participate in a three-week cognitive training with concurrent online high-definition tDCS application. Cognitive performance (primary), as well as Quality of Life scores and Sleep data will be examined before, during and after the intervention. In order to draw conclusions about the effect of tDCS in addition to cognitive training, a control group, receiving sham stimulation during training, will be assessed. A Follow-up session to assess long-term effects is planned four weeks after the post assessment. The results of the study will offer valuable insights into efficacy of combined tDCS and cognitive training intervention in women with PCCI in order to establish its potential to induce improvements in cognitive functions, and to beneficially affect patient-reported outcome measures.
Interventions
- Device Anodal tDCS
Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA). - Device Sham tDCS
Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants. - Behavioral Intensive cognitive training
Intensive cognitive training of a letter memory updating task, 9 sessions for approximately 20 min
Primary outcome measures
- Working memory performance at post-assessment [Time frame: 3 weeks]
Secondary outcome measures (7)
- Working memory performance at follow-up assessment [Time frame: 4 weeks after training]
- Working memory training performance (Letter Updating Task) at post-assessment [Time frame: 3 weeks]
- Working memory training performance (Letter Updating Task) at follow-up assessment [Time frame: 4 weeks after training]
- Quality of Life at post-assessment [Time frame: 3 weeks]
- Quality of Life at follow-up assessment [Time frame: 4 weeks after training]
- Visuo-spatial performance at post-assessment [Time frame: 3 weeks]
- Visuo-spatial performance at follow-up assessment [Time frame: 3 weeks]
Eligibility criteria
Inclusion criteria
- Chemotherapy to treat breast cancer (≥ 6 months post-treatment).
- Self-reported concerns regarding cognitive functioning.
- Age: 18-65 years.
- right-handedness
Exclusion criteria
- History of dementia before treatment of cancer.
- Other neurodegenerative neurological disorders; epilepsy or history of seizures.
- Severe and untreated medical conditions that preclude participation in the training, as determined by responsible physician.
- History of moderate to severe substance use disorder according to DSM-5
- Moderate to severe acute psychiatric disorders according to DSM-5
- Contraindication to tDCS application (Antal et al., 2017)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- University Medicine Greifswald — Greifswald
Publications
- Rocke M, Knochenhauer E, Thams F, Antonenko D, Fromm AE, Jansen N, Aziziaram S, Grittner U, Schmidt S, Vogelgesang A, Brakemeier EL, Floel A. Neuromodulation through brain stimulation-assisted cognitive training in patients with post-chemotherapy subjective cognitive impairment (Neuromod-PCSCI) after breast cancer: study protocol for a double-blinded randomised controlled trial. BMJ Open. 2025 May PMID 40398955
Identifiers
NCT: NCT04817566 · NeuroMod-PCCI