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Behavioural Intervention

BCI-Controlled NMES for Stroke

N/A
Waitlist Available
Research Sponsored by University Hospital, Geneva
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up difference between the week before intervention and 12 weeks after stroke onset
Awards & highlights

Study Summary

This trial will test whether NMES applied contingent to voluntary activation of primary motor cortex, as detected by a brain-computer interface, can improve recovery of patients with severe upper limb movement deficits.

Who is the study for?
This trial is for stroke patients who've had a stroke within the last 8 weeks and have severe arm weakness. They must be able to consent to treatment. People with a second stroke, skull issues, pacemakers, brain implants, severe confusion or language problems, extreme muscle tightness or other serious diseases can't join.Check my eligibility
What is being tested?
The study tests if using a brain-computer interface (BCI) to control electrical stimulation of weak muscles (NMES) helps recovery after a stroke. It compares BCI-NMES with Sham-NMES (a pretend treatment), starting treatments within two months of the stroke.See study design
What are the potential side effects?
Possible side effects may include discomfort from the electrical stimulation, skin irritation at the electrode sites, fatigue due to therapy sessions and potential headaches from wearing EEG equipment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~difference between the week before the intervention and the week after intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and difference between the week before the intervention and the week after intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Upper Limb Fugl-Meyer Score, after treatment
Secondary outcome measures
Change in electroencephalography functional connectivity
Change in fractional anisotropy (FA) of the cortico-spinal tract as determined from diffusion tensor imaging
Change in motor evoked potential amplitude of the paretic arm
Other outcome measures
Change in Functional Independence Measure (FIM) score, after intervention
Change in Functional Independence Measure (FIM) score, follow up
Change in Modified Ashworth Score, after intervention
+8 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: BCI-NMESActive Control1 Intervention
Electrical stimulation of paretic upper limb is triggered contigent to voluntary motor cortex activation of the patient, as detected by the brain-computer interface.
Group II: Sham-NMESPlacebo Group1 Intervention
Electrical stimulation of paretic upper limb is applied independently of motor cortex activation of the patient by using a prerecorded session of another patient.

Find a Location

Who is running the clinical trial?

University Hospital, GenevaLead Sponsor
491 Previous Clinical Trials
1,859,739 Total Patients Enrolled
13 Trials studying Stroke
4,116 Patients Enrolled for Stroke
Clinique Romande de ReadaptationNETWORK
15 Previous Clinical Trials
1,438 Total Patients Enrolled
3 Trials studying Stroke
97 Patients Enrolled for Stroke
Ecole Polytechnique Fédérale de LausanneOTHER
50 Previous Clinical Trials
100,620 Total Patients Enrolled
9 Trials studying Stroke
345 Patients Enrolled for Stroke

Media Library

BCI-NMES (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03379532 — N/A
BCI-NMES (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03379532 — N/A
Stroke Research Study Groups: Sham-NMES, BCI-NMES
Stroke Clinical Trial 2023: BCI-NMES Highlights & Side Effects. Trial Name: NCT03379532 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
BCI-controlled NMES in Subacute Stroke
Adrian Guggisberg 2018. "BCI-controlled NMES in Subacute Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03379532.
~4 spots leftby Apr 2025
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