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Completed

NCT Number: NCT05466487

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

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.

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Key information

Conditions

Spatial Neglect

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Limburg, 6200 MD, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transcranial alternating current stimulation (tACS)

Device

Stimulation frequency and peak-to-peak intensity will be set to 10Hz and 1.5 milliampere (mA), phase offset will be set to 0 and 100 cycles will be used for ramping up. At the start of the neglect training session, the tACS will be started. When the neglect training session is finished, after maximally 40 minutes, the tACS will be switched off.

Visual Scanning Training (VST)

Behavioral

The most common treatment for neglect is VST, which is an intensive compensation training (see Dutch guidelines for rehabilitation of neglect: Ten Brink, Van Kessel, & Nijboer, 2017). The aim of this training is to improve visual scanning behavior, that is, to encourage neglect patients to actively and consciously pay attention to stimuli on the contralesional side.

Primary outcomes

  1. Star Cancellation Task

    Time frame: 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 outcomes

  1. Computerized Visual Detection Task

    Time frame: 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

  2. McIntosh Line Bisection Task-digitized

    Time frame: 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

  3. Schenkenberg Line Bisection Task

    Time frame: 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

  4. Baking Tray Task

    Time frame: 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

  5. Catherine Bergego Scale

    Time frame: 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).

  6. Subjective Neglect Questionnaire

    Time frame: 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).

Other outcomes

  1. EEG

    Time frame: Testing will take place before the training (T0; baseline), and after the eighteenth (T3) training session.

    Power of alpha frequency band

Sponsors and collaborators

Lead sponsor

Maastricht University

Other

Registry information

Official study title

Transcranial Alternating Stimulation in Rehabilitation: a Randomized Controlled Trial in Chronic Stroke Patients With Visuospatial Neglect

Acronym: NibsNeglect

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2022
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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