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

NCT ID: NCT04817566

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2026-06-30

Brief Summary

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.

Conditions

Breast Cancer; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

stimulation group

Anodal tDCS+ intensive cognitive Training

Group Type: EXPERIMENTAL

Anodal tDCS

Intervention Type: DEVICE

Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA).

Intensive cognitive training

Intervention Type: BEHAVIORAL

Intensive cognitive training of a letter memory updating task, 9 sessions for approximately 20 min

sham group

Sham tDCS + intensive cognitive Training

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: DEVICE

Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants.

Intensive cognitive training

Intervention Type: BEHAVIORAL

Intensive cognitive training of a letter memory updating task, 9 sessions for approximately 20 min

Interventions

Anodal tDCS

Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA).

Intervention Type: DEVICE

Sham tDCS

Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants.

Intervention Type: DEVICE

Intensive cognitive training

Intensive cognitive training of a letter memory updating task, 9 sessions for approximately 20 min

Intervention Type: BEHAVIORAL

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Greifswald

OTHER

Sponsor Role: collaborator

University Medicine Greifswald

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agnes Flöel, Prof.

Role: STUDY_DIRECTOR

University Medicine Greifswald

Locations

University Medicine Greifswald

Greifswald, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Agnes Flöel, Prof.

Role: CONTACT

agnes.floeel@med.uni-greifswald.de

0049 3834 86 6815

Daria Antonenko, Dr.

Role: CONTACT

daria.antonenko@med.uni-greifswald.de

0049 3834 86 6754

Facility Contacts

Agnes Flöel, Prof.

Role: primary

agnes.floeel@med.uni-greifswald.de

0049 3834 86 6815

References

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 21;15(5):e096162. doi: 10.1136/bmjopen-2024-096162.

Reference Type: DERIVED

PMID: 40398955 (View on PubMed)

Other Identifiers

NeuroMod-PCCI

Identifier Type: -

Identifier Source: org_study_id