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

Maastricht University

Status: Completed

Conditions: Spatial Neglect

Treatments: Behavioral: Visual Scanning Training (VST); Device: Transcranial Alternating Current Stimulation (tACS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05466487

NL70256.068.19

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups

Active tACS

Experimental group

Treatment:

Device: Transcranial Alternating Current Stimulation (tACS)

Behavioral: Visual Scanning Training (VST)

Sham tACS

Sham Comparator group

Treatment:

Device: Transcranial Alternating Current Stimulation (tACS)

Behavioral: Visual Scanning Training (VST)