NeuroMod-PCCIRecruiting

Cognitive Training and Brain Stimulation in Women with Cognitive Impairments Following Chemotherapy

Gender
Women
Age
18–65 years
Trial type
Interventional
Line of therapy
all
Phase

What is this trial about?

The standard treatment for breast cancer, especially in advanced stages, includes chemotherapy, which can lead to cognitive impairments. The goal of the NeuroMod-PCCI study is to investigate whether a combination of intensive cognitive training and brain stimulation (high-resolution transcranial direct current stimulation, tDCS) can improve cognitive function in women after chemotherapy. Women between the ages of 18 and 65 who are undergoing chemotherapy for breast cancer and who report experiencing cognitive impairment are eligible to participate in the study.

Trial flow

Requirements

Diagnosis: Breast Cancer

Age: 18–65 years

Line of therapy: Unabhängig von Therapielinie

Key inclusion criteria: Chemotherapy (≥ 6 months post-treatment); self-reported concerns regarding cognitive functioning; right-handedness

Allocation

Randomisierung

Treatment

approx. 3 weeks
Transcranial direct current stimulation (tDCS) + Intensive cognitive training9 sessions with 20 minutes stimulation each (2 mA), Intensive cognitive training of a letter memory updating task, 9 sessions for approximately 20 min
palcebo transcranial direct current stimulation (tDCS) + Intensive cognitive training9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants, Intensive cognitive training of a letter memory updating task, 9 sessions for approximately 20 min

Follow-up

1 months

Detailed description

Post-chemotherapy cognitive impairments (PCCI) affect many women who have undergone chemotherapy for breast cancer. These impairments often affect working memory, attention, and other cognitive functions and can significantly impair the quality of life of those affected. Some studies have shown that cognitive training can have positive effects on memory and cognitive performance. This cognitive training focuses on working memory, particularly through a task in which letters must be recalled in a specific order. Transcranial direct current stimulation (tDCS) is increasingly being investigated as a potential means of improving cognitive functions. In this procedure, a weak electrical current is conducted through the scalp via adhesive electrodes. In Germany, tDCS is being investigated in clinical trials for the treatment of various conditions. To date, tDCS is not used as a routine treatment in everyday clinical practice.

The aim of this study is to investigate whether cognitive training combined with high-resolution transcranial direct current stimulation can help improve cognitive functions. Patients are randomly assigned to two groups: One group receives tDCS in combination with cognitive training (treatment arm). The other group receives the same cognitive training plus a placebo tDCS treatment (control arm). In this case, patients are given the impression of receiving a real treatment, but the current intensity is too low to deliver any actual electrical stimulation. The study is double-blind, meaning that neither the patients nor the researchers know which treatment is being administered. The study consists of a total of 9 training sessions over a period of three weeks, and the effects of the treatment are assessed before, during, and after the training, as well as four weeks after the treatment is completed. The outcomes being measured include, among other things, improvements in cognitive performance, the patients’ quality of life, and sleep quality.

Women between the ages of 18 and 65 who have undergone chemotherapy as part of breast cancer treatment and who report cognitive impairments at least 6 months after treatment are eligible to participate in the study. Participants must also be right-handed.

Facts

  1. Disease: Breast cancer (breast carcinoma)
  2. Cancer characteristics: Treatment with chemotherapy
  3. What the study investigates: The effect of brain stimulation and cognitive training on cognitive function after chemotherapy
  4. Study objective: To improve cognitive performance by combining the two forms of therapy
  5. Study duration: Total duration of 3 weeks for training, follow-up examination 4 weeks after completion
  6. Study characteristics: randomized, double-blind, two groups

Trial sites

1 trial site in Germany is listed.

  • Universitätsmedizin Greifswald - Körperschaft des Öffentlichen Rechts

    Greifswald

    Recruiting

This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.

Medical editorial team

  • Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
  • PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine

This description is based on the public trial registry (NCT04817566) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.