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

Breast Cancer Clinical Trial

— NeuroMod-PCCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04817566
• Other study ID #: NeuroMod-PCCI
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: August 2024

Study information

• Verified date: June 2023
• Source: University Medicine Greifswald
• Contact: Agnes Flöel, Prof.
• Phone: 0049 3834 86 6815
• Email: agnes.floeel[@]med.uni-greifswald.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

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

2. Self-reported concerns regarding cognitive functioning.

3. Age: 18-60 years.

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)

Related Conditions & MeSH terms

• Breast Cancer
• Chemotherapy-Related Cognitive Impairment
• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Device:
• Anodal tDCS
Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA).
• Sham tDCS
Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants.

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

Locations

Country	Name	City	State
Germany	University Medicine Greifswald	Greifswald

Sponsors (2)

Lead Sponsor	Collaborator
University Medicine Greifswald	University of Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	4 weeks after training
Secondary	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	3 weeks
Secondary	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	4 weeks after training
Secondary	Quality of Life at post-assessment	PROMIS score for HRQoL (PROPr score) and scores of subscales (e.g. cognitive function)	3 weeks
Secondary	Quality of Life at follow-up assessment	PROMIS score for HRQoL (PROPr score) and scores of subscales (e.g. cognitive function)	4 weeks after training
Secondary	Visuo-spatial performance at post-assessment	Visuo-spatial performance at post-assessment operationalized by number of correctly recalled items in the VR task.	3 weeks
Secondary	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.	3 weeks