Breast CancerNeuroMod-PCCINCT04817566
Cognitive Training and Brain Stimulation in Women With Post-chemotherapy Cognitive Impairment
A study testing Anodal tDCS and Intensive cognitive training in people with Breast Cancer and Cognitive Impairment, run by University Medicine Greifswald at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Cognitive Impairment
- What is being tested?
- Anodal tDCS and Intensive cognitive training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteGermany
- Study dates
- 2 Nov 2021to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chemotherapy to treat breast cancer (≥ 6 months post-treatment).
- Self-reported concerns regarding cognitive functioning.
- Age: 18-65 years.
- right-handedness
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medicine Greifswald
Greifswald
Agnes Flöel, Prof., 0049 3834 86 6815, agnes.floeel@med.uni-greifswald.de
About this study
Official title: Neuromodulation Through Brain Stimulation-assisted Cognitive Training in Patients 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.
Read the 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
- Being tested
- Anodal tDCS, Sham tDCS, Intensive cognitive training
- Medical subject headings
- Breast Neoplasms, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCSDevice
Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA).
Sham tDCSDevice
Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants.
Intensive cognitive trainingBehavioural
Intensive cognitive training of a letter memory updating task, 9 sessions for approximately 20 min
| Study group | Role | What they receive |
|---|---|---|
| stimulation group | Experimental | Anodal tDCS+ intensive cognitive Training Receives: Device: Anodal tDCS; Behavioral: Intensive cognitive training |
| sham group | Sham comparator | Sham tDCS + intensive cognitive Training Receives: Device: Sham tDCS; Behavioral: Intensive cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 weeks
Secondary outcomes (7)
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
Measured: 4 weeks after training
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
Measured: 3 weeks
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
Measured: 4 weeks after training
Quality of Life at post-assessment
PROMIS score for HRQoL (PROPr score) and scores of subscales (e.g. cognitive function)
Measured: 3 weeks
Quality of Life at follow-up assessment
PROMIS score for HRQoL (PROPr score) and scores of subscales (e.g. cognitive function)
Measured: 4 weeks after training
Visuo-spatial performance at post-assessment
Visuo-spatial performance at post-assessment operationalized by number of correctly recalled items in the VR task.
Measured: 3 weeks
Visuo-spatial performance at follow-up assessment
Visuo-spatial performance at follow-up assessment operationalized by number of correctly recalled items in the VR task.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start2 Nov 2021
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- University of Greifswald
- Responsible party
- Sponsor
- Investigators
- Agnes Flöel, Prof., Study director, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817566
- Sponsor's protocol ID
- NeuroMod-PCCI
- Acronym
- NeuroMod-PCCI
- Status last verified
- Apr 2025
- First submitted
- 24 Mar 2021
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40398955
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation Through Brain Stimulation-assisted Cognitive Training in Patients With Post-chemotherapy Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04817566
- Acronym / sponsor ID
- NeuroMod-PCCI / NeuroMod-PCCI
- Conditions
- Breast Cancer, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- University of Greifswald
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stimulation group | Experimental | Device: Anodal tDCS, Behavioral: Intensive cognitive trainingAnodal tDCS+ intensive cognitive Training |
| sham group | Sham comparator | Device: Sham tDCS, Behavioral: Intensive cognitive trainingSham tDCS + intensive cognitive Training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chemotherapy to treat breast cancer (≥ 6 months post-treatment).
- Self-reported concerns regarding cognitive functioning.
- Age: 18-65 years.
- right-handedness
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal tDCSAnodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA). | Device | stimulation group |
| Sham tDCSSham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants. | Device | sham group |
| Intensive cognitive trainingIntensive cognitive training of a letter memory updating task, 9 sessions for approximately 20 min | Behavioural | sham group, stimulation group |
Primary outcome
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
7 secondary outcomes
Working memory performance at follow-up assessment
Time frame: 4 weeks after training
Working memory training performance (Letter Updating Task) at post-assessment
Time frame: 3 weeks
Working memory training performance (Letter Updating Task) at follow-up assessment
Time frame: 4 weeks after training
Quality of Life at post-assessment
Time frame: 3 weeks
Quality of Life at follow-up assessment
Time frame: 4 weeks after training
Visuo-spatial performance at post-assessment
Time frame: 3 weeks
Visuo-spatial performance at follow-up assessment
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Derived from this study: PubMed 40398955Rocke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Agnes Flöel, Prof. study director
University Medicine Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tDCS and Intensive cognitive training in people with Breast Cancer and Cognitive Impairment, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agnes Flöel, Prof. (0049 3834 86 6815, agnes.floeel@med.uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Working memory performance at post-assessment (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04817566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.