NCT04817566

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
1mo left

Started Nov 2021

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Nov 2021Jun 2026

First Submitted

Initial submission to the registry

March 24, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

November 2, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

4.6 years

First QC Date

March 24, 2021

Last Update Submit

April 1, 2025

Conditions

Breast CancerCognitive Impairment

Outcome Measures

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

    3 weeks

Secondary Outcomes (7)

  • Working memory performance at follow-up assessment

    4 weeks after training

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

    3 weeks

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

    4 weeks after training

  • Quality of Life at post-assessment

    3 weeks

  • Quality of Life at follow-up assessment

    4 weeks after training

  • +2 more secondary outcomes

Study Arms (2)

stimulation group

EXPERIMENTAL

Anodal tDCS+ intensive cognitive Training

Device: Anodal tDCSBehavioral: Intensive cognitive training

sham group

SHAM COMPARATOR

Sham tDCS + intensive cognitive Training

Device: Sham tDCSBehavioral: Intensive cognitive training

Interventions

Anodal tDCSDEVICE

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

stimulation group
Sham tDCSDEVICE

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

sham group
Intensive cognitive trainingBEHAVIORAL

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

sham groupstimulation group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chemotherapy to treat breast cancer (≥ 6 months post-treatment).
  • Self-reported concerns regarding cognitive functioning.
  • Age: 18-65 years.
  • right-handedness

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medicine Greifswald

Greifswald, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40398955DERIVED

MeSH Terms

Conditions

Breast NeoplasmsCognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Agnes Flöel, Prof.

    University Medicine Greifswald

    STUDY DIRECTOR

Central Study Contacts

Agnes Flöel, Prof.

CONTACT

0049 3834 86 6815agnes.floeel@med.uni-greifswald.de

Daria Antonenko, Dr.

CONTACT

0049 3834 86 6754daria.antonenko@med.uni-greifswald.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 26, 2021

Study Start

November 2, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)