Cognitive Training and Brain Stimulation in Women With Post-chemotherapy Cognitive Impairment

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	Female

More 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04817566
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Medicine Greifswald
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Agnes Flöel, Prof.
Principal Investigator Affiliation	University Medicine Greifswald
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Breast Cancer, Cognitive Impairment

Additional Details

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.

Arms & Interventions

Arms

Experimental: stimulation group

Anodal tDCS+ intensive cognitive Training

Sham Comparator: sham group

Sham tDCS + intensive cognitive Training

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

Contact a Trial Team

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International Sites

University Medicine Greifswald, Greifswald, Germany

Status

Recruiting

Address

University Medicine Greifswald

Greifswald, ,

Site Contact

Agnes Flöel, Prof.

[email protected]

0049 3834 86 6815

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