Cognitive Training and Brain Stimulation in Women With Post-chemotherapy Cognitive Impairment (NeuroMod-PCCI)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Cognitive Impairment
• Intervention / Treatment: Device: Anodal tDCS; Behavioral: Intensive cognitive training; Device: Sham tDCS

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 Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agnes Flöel, Prof.; Phone Number: 0049 3834 86 6815; Email: agnes.floeel@med.uni-greifswald.de
• Study Contact Backup: Name: Daria Antonenko, Dr.; Phone Number: 0049 3834 86 6754; Email: daria.antonenko@med.uni-greifswald.de

Study Locations

• Germany
  • Greifswald, Germany
    • Recruiting
    • University Medicine Greifswald
    • Contact: Agnes Flöel, Prof.; Phone Number: 0049 3834 86 6815; Email: agnes.floeel@med.uni-greifswald.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stimulation group; Anodal tDCS+ intensive cognitive Training	Device: Anodal tDCS; Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA).; Behavioral: Intensive cognitive training; Intensive cognitive training of a letter memory updating task, 9 sessions for approximately 20 min
Sham Comparator: sham group; Sham tDCS + intensive cognitive Training	Behavioral: Intensive cognitive training; Intensive cognitive training of a letter memory updating task, 9 sessions for approximately 20 min; Device: Sham tDCS; Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Quality of Life at post-assessment	PROMIS score for HRQoL (PROPr score) and scores of subscales (e.g. cognitive function)	3 weeks
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
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

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Collaborators: University of Greifswald
• Investigators: Study Director: Agnes Flöel, Prof., University Medicine Greifswald

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions; Chemotherapy-Related Cognitive Impairment; Cognitive Dysfunction
• Other Study ID Numbers: NeuroMod-PCCI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No