Health TrialsbyHealthPanel

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

ConditionsBreast CancerCognitive Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorUniversity Medicine Greifswald

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Chemotherapy to treat breast cancer (≥ 6 months post-treatment).

Self-reported concerns regarding cognitive functioning.

Age: 18-65 years.

right-handedness

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: stimulation groupExperimental treatment 2 interventions
Group B: sham groupSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Working memory performance at post-assessment

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

Time frame
3 weeks

Secondary outcomes

1

Working memory performance at follow-up assessment

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

Time frame
4 weeks after training
2

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

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

Time frame
3 weeks
3

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

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

Time frame
4 weeks after training
4

Quality of Life at post-assessment

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

Time frame
3 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medicine Greifswald

Lead sponsor

University of Greifswald

Collaborator

Source ClinicalTrials.gov
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