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

M

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

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)

Trial contacts and locations

0

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Central trial contact

Marij Middag, MSc

Data sourced from clinicaltrials.gov

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