Clinical trial NCT05466487: Non-Invasive Brain Stimulation as an Innovative Treatment for Chronic Neglect Patients
Official title: Transcranial Alternating Stimulation in Rehabilitation: a Randomized Controlled Trial in Chronic Stroke Patients With Visuospatial Neglect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spatial Neglect
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Star Cancellation Task
timeFrame: 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.
Secondary outcomes:
measure: Computerized Visual Detection Task
timeFrame: 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.
measure: McIntosh Line Bisection Task-digitized
timeFrame: 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.
measure: Schenkenberg Line Bisection Task
timeFrame: 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.
measure: Baking Tray Task
timeFrame: 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.
measure: Catherine Bergego Scale
timeFrame: 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.
measure: Subjective Neglect Questionnaire
timeFrame: 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.
Other outcomes:
measure: EEG
timeFrame: Testing will take place before the training (T0; baseline), and after the eighteenth (T3) training session.
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
affiliation: Maastricht University
name: Alexander T. Sack, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Middag-van Spanje M, Schuhmann T, Nijboer T, van der Werf O, Sack AT, van Heugten C. Study protocol of transcranial electrical stimulation at alpha frequency applied during rehabilitation: A randomized controlled trial in chronic stroke patients with visuospatial neglect. BMC Neurol. 2022 Nov 2;22(1):402. doi: 10.1186/s12883-022-02932-7.