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NCT Number: NCT04817566

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Anodal tDCS

Device

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

Sham tDCS

Device

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

Intensive cognitive training

Behavioral

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

Primary outcomes

  1. Working memory performance at post-assessment

    Time frame: 3 weeks

    Performance in a near transfer task (n-back) under anodal tDCS compared to sham condition; operationalized by % correct responses in the n-back task

Secondary outcomes

  1. Working memory performance at follow-up assessment

    Time frame: 4 weeks after training

    Performance in a near transfer task (n-back) under anodal tDCS compared to sham condition; operationalized by % correct responses in the n-back task

  2. Working memory training performance (Letter Updating Task) at post-assessment

    Time frame: 3 weeks

    Performance in primary memory training task (Letter Updating Task) at post-assessment, operationalized by number of correctly recalled lists in the letter updating task

  3. Working memory training performance (Letter Updating Task) at follow-up assessment

    Time frame: 4 weeks after training

    Performance in primary memory training task (Letter Updating Task) at follow-up assessment, operationalized by number of correctly recalled lists in the letter updating task

  4. Quality of Life at post-assessment

    Time frame: 3 weeks

    PROMIS score for HRQoL (PROPr score) and scores of subscales (e.g. cognitive function)

  5. Quality of Life at follow-up assessment

    Time frame: 4 weeks after training

    PROMIS score for HRQoL (PROPr score) and scores of subscales (e.g. cognitive function)

  6. Visuo-spatial performance at post-assessment

    Time frame: 3 weeks

    Visuo-spatial performance at post-assessment operationalized by number of correctly recalled items in the VR task.

  7. Visuo-spatial performance at follow-up assessment

    Time frame: 3 weeks

    Visuo-spatial performance at follow-up assessment operationalized by number of correctly recalled items in the VR task.

Study contacts

Contact information is provided by the study sponsor or research team.

Agnes Flöel, Prof.

CONTACT

[email protected]

0049 3834 86 6815

Daria Antonenko, Dr.

CONTACT

[email protected]

0049 3834 86 6754

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Collaborators

  • University of Greifswald

Registry information

Official study title

Neuromodulation Through Brain Stimulation-assisted Cognitive Training in Patients With Post-chemotherapy Cognitive Impairment

Acronym: NeuroMod-PCCI

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 26, 2021
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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