BCI-controlled NMES in Subacute Stroke
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
BCI-NMES
Sham-NMES
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Ischemic or hemorrhagic stroke
- Stroke onset ≤ 8 weeks
- Severe, unilateral motor upper extremity hemiparesis (≤15 Fugl-Meyer Score)
- Ability to give informed consent
Exclusion Criteria:
- Second stroke during rehabilitation
- Skull breach
- Cardiac pacemaker
- Metallic implants in the brain
- Delirium or disturbed vigilance
- Inability to follow treatments sessions
- Severe language comprehension deficits
- Severe dystonia or spasticity
- Severe co-morbidity (ex, traumatic, rheumatologic, neurodegenerative diseases)
- Pregnancy
Sites / Locations
- University of Austin
- Division of Neurorehabilitation, University Hospital of GenevaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
BCI-NMES
Sham-NMES
Arm Description
Electrical stimulation of paretic upper limb is triggered contigent to voluntary motor cortex activation of the patient, as detected by the brain-computer interface.
Electrical stimulation of paretic upper limb is applied independently of motor cortex activation of the patient by using a prerecorded session of another patient.
Outcomes
Primary Outcome Measures
Change in Upper Limb Fugl-Meyer Score, after treatment
Scale 0-66, higher scores indicate better outcome
Secondary Outcome Measures
Change in motor evoked potential amplitude of the paretic arm
Continuous measure, higher amplitude changes indicate better outcome
Change in fractional anisotropy (FA) of the cortico-spinal tract as determined from diffusion tensor imaging
FA can have values between 0 and 1, higher values indicate better outcome
Change in electroencephalography functional connectivity
Computed from high-density EEG recordings. Continuous measure. Higher values indicate better outcome.
Full Information
NCT ID
NCT03379532
First Posted
December 14, 2017
Last Updated
May 9, 2023
Sponsor
University Hospital, Geneva
Collaborators
Ecole Polytechnique Fédérale de Lausanne, Clinique Romande de Readaptation
1. Study Identification
Unique Protocol Identification Number
NCT03379532
Brief Title
BCI-controlled NMES in Subacute Stroke
Official Title
Brain-computer Interface Controlled Neuromuscular Electrical Stimulation in Subacute Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2018 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
Collaborators
Ecole Polytechnique Fédérale de Lausanne, Clinique Romande de Readaptation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Stroke patients with severe upper limb movement deficits have limited treatment options and often remain severely handicapped at the chronic stage.
Recent findings have suggested that poor motor recovery can be due to severe damage of the cortico-spinal tract (CST), the neural fibres connecting the movement regions of the brain to the spinal cord. Hence, to improve recovery of upper limb movements it will be crucial to re-establish and strengthen CST projections.
Recent studies provided evidence that closed-loop brain computer interface-driven electrical stimulation of the paretic muscles can induce clinically important and lasting recovery of upper limb function, even in patients with chronic, severe motor affection. In this treatment approach, movement intentions of the patients are detected with electroencephalography and real-time analyses. This triggers an electrical stimulation of affected upper limb muscles.
In this study, the investigators hypothesize that neuromuscular electrical stimulation (NMES) applied contingent to voluntary activation of primary motor cortex, as detected by a brain-computer interface (BCI), can help restore CST projections. This might improve recovery of patients with severe upper limb movement deficits. Treatment will be started within the first 8 weeks after stroke onset.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BCI-NMES
Arm Type
Active Comparator
Arm Description
Electrical stimulation of paretic upper limb is triggered contigent to voluntary motor cortex activation of the patient, as detected by the brain-computer interface.
Arm Title
Sham-NMES
Arm Type
Sham Comparator
Arm Description
Electrical stimulation of paretic upper limb is applied independently of motor cortex activation of the patient by using a prerecorded session of another patient.
Intervention Type
Device
Intervention Name(s)
BCI-NMES
Intervention Description
From the recorded brain activity (EEG) subject specific patterns will be extracted with machine learning techniques from recordings where the subject executes movements tasks. Whenever a subject-specific pattern can be identified and detected, this is used for triggering neuromuscular electrical stimulation.
Intervention Type
Device
Intervention Name(s)
Sham-NMES
Intervention Description
Neuromuscular electrical stimulation is triggered independently of the patient's movement intentions.
Primary Outcome Measure Information:
Title
Change in Upper Limb Fugl-Meyer Score, after treatment
Description
Scale 0-66, higher scores indicate better outcome
Time Frame
Difference between the week before the intervention and the week after intervention
Secondary Outcome Measure Information:
Title
Change in motor evoked potential amplitude of the paretic arm
Description
Continuous measure, higher amplitude changes indicate better outcome
Time Frame
Difference between the week before the intervention and the week after intervention
Title
Change in fractional anisotropy (FA) of the cortico-spinal tract as determined from diffusion tensor imaging
Description
FA can have values between 0 and 1, higher values indicate better outcome
Time Frame
Difference between the week before the intervention and the week after intervention
Title
Change in electroencephalography functional connectivity
Description
Computed from high-density EEG recordings. Continuous measure. Higher values indicate better outcome.
Time Frame
Difference between the week before the intervention and the week after intervention
Other Pre-specified Outcome Measures:
Title
Change in Upper Limb Fugl-Meyer Score, follow up
Description
Scale 0-66, higher scores indicate better outcome
Time Frame
Difference between the week before intervention and 12 weeks after stroke onset
Title
Change in hand grip strength, after intervention
Description
Jamar dynamometer. Continous measure expressed in kilograms. Higher values indicate better outcome.
Time Frame
Difference between the week before the intervention and the week after intervention
Title
Change in hand grip strength, follow up
Description
Jamar dynamometer. Continous measure expressed in kilograms. Higher values indicate better outcome.
Time Frame
Difference between the week before intervention and 12 weeks after stroke onset
Title
Change in Functional Independence Measure (FIM) score, after intervention
Description
Range 18-126, higher values indicate better outcome.
Time Frame
Difference between the week before the intervention and the week after intervention
Title
Change in Functional Independence Measure (FIM) score, follow up
Description
Range 18-126, higher values indicate better outcome.
Time Frame
Difference between the week before intervention and 12 weeks after stroke onset
Title
Change in Semmes-Weinstein monofilament discrimination test, after intervention
Description
Range 0.04 to 60 g. Lower values indicate better outcome.
Time Frame
Difference between the week before the intervention and the week after intervention
Title
Change in Semmes-Weinstein monofilament discrimination test, follow up
Description
Range 0.04 to 60 g. Lower values indicate better outcome.
Time Frame
Difference between the week before intervention and 12 weeks after stroke onset
Title
Change in Modified Ashworth Score, after intervention
Description
Range 0 to 4. Lower values indicate better outcome.
Time Frame
Difference between the week before the intervention and the week after intervention
Title
Change in Modified Ashworth Score, follow up
Description
Range 0 to 4. Lower values indicate better outcome.
Time Frame
Difference between the week before intervention and 12 weeks after stroke onset
Title
Change in action research arm test (ARAT) score, after intervention
Description
Scale range 0-57 points, higher values indicate better outcome.
Time Frame
Difference between the week before the intervention and the week after intervention
Title
Change in action research arm test (ARAT) score, follow up
Description
Scale range 0-57 points, higher values indicate better outcome.
Time Frame
Difference between the week before intervention and 12 weeks after stroke onset
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ischemic or hemorrhagic stroke
Stroke onset ≤ 8 weeks
Severe, unilateral motor upper extremity hemiparesis (≤15 Fugl-Meyer Score)
Ability to give informed consent
Exclusion Criteria:
Second stroke during rehabilitation
Skull breach
Cardiac pacemaker
Metallic implants in the brain
Delirium or disturbed vigilance
Inability to follow treatments sessions
Severe language comprehension deficits
Severe dystonia or spasticity
Severe co-morbidity (ex, traumatic, rheumatologic, neurodegenerative diseases)
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adrian G Guggisberg, MD
Phone
223723521
Email
Adrian.Guggisberg@hcuge.ch
Facility Information:
Facility Name
University of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José del R. Millán, PhD
Email
jose.millan@austin.utexas.edu
Facility Name
Division of Neurorehabilitation, University Hospital of Geneva
City
Geneva
State/Province
GE
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrian G Guggisberg, MD
Phone
+41223723521
Email
adrian.guggisberg@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Adrian G Guggisberg, MD
12. IPD Sharing Statement
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BCI-controlled NMES in Subacute Stroke
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