Non-Invasive Brain Stimulation as an Innovative Treatment for Chronic Neglect Patients

Not Applicable

Completed

• Conditions: Spatial Neglect
• Interventions: Device: Transcranial Alternating Current Stimulation (tACS); Behavioral: Visual Scanning Training (VST)

• Registration Number: NCT05466487
• Lead Sponsor: Maastricht University

Brief Summary

Background Stroke is a leading cause of neurological impairments in language, motor and cognitive functions. Next to traditional stroke treatment, Non-Invasive Brain Stimulation (NIBS) offers the potential to facilitate stroke recovery as a complementary approach. Here, we aim at exploiting the principles of NIBS, specifically transcranial Alternating Current Stimulation (tACS), to promote functional recovery of people with neglect symptoms following stroke.

Objective To determine whether neglect training complemented with tACS treatment in chronic stroke patients suffering from neglect improves neglect-related symptoms compared to neglect training with sham stimulation.

Study design Double-blind randomized placebo-controlled intervention study. After enrollment and completion of baseline measurements, participants are randomly assigned to either the active tACS group or sham (control) group.

Intervention We will combine an evidence based visual scanning training (VST) with 40 minutes of (active or sham) tACS at alpha frequency. The intervention is administered three times a week for a duration of six weeks.

Outcomes of the study Performance on standard, conventional neuropsychological tests, as well as on ADL observation scales.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-21
• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-20
• Primary Completion: 2023-03-24
• Study Completion: 2023-03-24
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• neurologically objectified stroke;
• stroke occurred when patient was 18-80 years of age;
• chronic stroke (>6 months post-stroke onset);
• sufficient comprehension and communication skills to benefit from training (based on clinical judgement); and
• a screening containing four neuropsychological tests will be performed to evaluate the current severity of the neglect, since the diagnosis of neglect may have been established months or even years ago in our sample of chronic stroke patients.

Exclusion Criteria

• currently engaging in cognitive rehabilitation treatment or neglect treatment;

• physically or mentally unable to participate (based on clinical judgment);

• hemianopsia (based on clinical judgement);

• severe communicative disability, as task descriptions need to be understood;

• local scalp injuries*;

• eczema on scalp or psoriasis*;

• diagnosed (neuro)psychiatric or neurodegenerative diseases*;

• current alcohol and/or drug abuse*; and

• pregnancy*.

  • due to tACS safety considerations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tACS	Transcranial Alternating Current Stimulation (tACS)	-
Sham tACS	Visual Scanning Training (VST)	-
Active tACS	Transcranial Alternating Current Stimulation (tACS)	-
Active tACS	Visual Scanning Training (VST)	-

Primary Outcome Measures

Name	Time	Method
Star Cancellation Task	Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.	Quality of search score

Secondary Outcome Measures

Name	Time	Method
Computerized Visual Detection Task	Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.	Sum of weighted hits
McIntosh Line Bisection Task-digitized	Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.	Endpoint weightings bias
Schenkenberg Line Bisection Task	Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.	Relative deviation score
Baking Tray Task	Testing will take place before the training (T0; baseline), after the ninth (T2) training session, as well as one week (T4) and three months (T5) after termination of the training.	Average x-coordinate
Catherine Bergego Scale	Testing will take place before the training (T0; baseline), after the ninth (T2) training session, as well as one week (T4) and three months (T5) after termination of the training.	Total score. The CBS is a 10-item observation scale, and results in a total score of 0 (no neglect) to 30 (severe neglect).
Subjective Neglect Questionnaire	Testing will take place before the training (T0; baseline), after the ninth (T2) training session, as well as one week (T4) and three months (T5) after termination of the training.	Total score. The SNQ is a 19-item questionnaire, and results in a total score of 19 (no reported problems) to 95 (many/frequently reported problems).

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Limburg, Netherlands