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Trial record 8 of 23 for:    BCI | Stroke

BCI-controlled NMES in Subacute Stroke

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ClinicalTrials.gov Identifier: NCT03379532
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
Ecole Polytechnique Fédérale de Lausanne
Clinique Romande de Readaptation
Information provided by (Responsible Party):
Adrian Guggisberg, University Hospital, Geneva

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.


Condition or disease Intervention/treatment Phase
Stroke Device: BCI-NMES Device: Sham-NMES Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brain-computer Interface Controlled Neuromuscular Electrical Stimulation in Subacute Stroke
Actual Study Start Date : January 26, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Active Comparator: BCI-NMES
Electrical stimulation of paretic upper limb is triggered contigent to voluntary motor cortex activation of the patient, as detected by the brain-computer interface.
Device: BCI-NMES
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.

Sham Comparator: Sham-NMES
Electrical stimulation of paretic upper limb is applied independently of motor cortex activation of the patient by using a prerecorded session of another patient.
Device: Sham-NMES
Neuromuscular electrical stimulation is triggered independently of the patient's movement intentions.




Primary Outcome Measures :
  1. Change in Upper Limb Fugl-Meyer Score, after treatment [ Time Frame: Difference between the week before the intervention and the week after intervention ]
    Scale 0-66, higher scores indicate better outcome


Secondary Outcome Measures :
  1. Change in motor evoked potential amplitude of the paretic arm [ Time Frame: Difference between the week before the intervention and the week after intervention ]
    Continuous measure, higher amplitude changes indicate better outcome

  2. Change in fractional anisotropy (FA) of the cortico-spinal tract as determined from diffusion tensor imaging [ Time Frame: Difference between the week before the intervention and the week after intervention ]
    FA can have values between 0 and 1, higher values indicate better outcome

  3. Change in electroencephalography functional connectivity [ Time Frame: Difference between the week before the intervention and the week after intervention ]
    Computed from high-density EEG recordings. Continuous measure. Higher values indicate better outcome.


Other Outcome Measures:
  1. Change in Upper Limb Fugl-Meyer Score, follow up [ Time Frame: Difference between the week before intervention and 12 weeks after stroke onset ]
    Scale 0-66, higher scores indicate better outcome

  2. Change in hand grip strength, after intervention [ Time Frame: Difference between the week before the intervention and the week after intervention ]
    Jamar dynamometer. Continous measure expressed in kilograms. Higher values indicate better outcome.

  3. Change in hand grip strength, follow up [ Time Frame: Difference between the week before intervention and 12 weeks after stroke onset ]
    Jamar dynamometer. Continous measure expressed in kilograms. Higher values indicate better outcome.

  4. Change in Functional Independence Measure (FIM) score, after intervention [ Time Frame: Difference between the week before the intervention and the week after intervention ]
    Range 18-126, higher values indicate better outcome.

  5. Change in Functional Independence Measure (FIM) score, follow up [ Time Frame: Difference between the week before intervention and 12 weeks after stroke onset ]
    Range 18-126, higher values indicate better outcome.

  6. Change in Semmes-Weinstein monofilament discrimination test, after intervention [ Time Frame: Difference between the week before the intervention and the week after intervention ]
    Range 0.04 to 60 g. Lower values indicate better outcome.

  7. Change in Semmes-Weinstein monofilament discrimination test, follow up [ Time Frame: Difference between the week before intervention and 12 weeks after stroke onset ]
    Range 0.04 to 60 g. Lower values indicate better outcome.

  8. Change in Modified Ashworth Score, after intervention [ Time Frame: Difference between the week before the intervention and the week after intervention ]
    Range 0 to 4. Lower values indicate better outcome.

  9. Change in Modified Ashworth Score, follow up [ Time Frame: Difference between the week before intervention and 12 weeks after stroke onset ]
    Range 0 to 4. Lower values indicate better outcome.

  10. Change in action research arm test (ARAT) score, after intervention [ Time Frame: Difference between the week before the intervention and the week after intervention ]
    Scale range 0-57 points, higher values indicate better outcome.

  11. Change in action research arm test (ARAT) score, follow up [ Time Frame: Difference between the week before intervention and 12 weeks after stroke onset ]
    Scale range 0-57 points, higher values indicate better outcome.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379532


Contacts
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Contact: Adrian G Guggisberg, MD 223723521 Adrian.Guggisberg@hcuge.ch

Locations
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Switzerland
Division of Neurorehabilitation, University Hospital of Geneva Recruiting
Geneva, GE, Switzerland, 1211
Contact: Adrian G Guggisberg, MD    +41223723521    adrian.guggisberg@hcuge.ch   
Principal Investigator: Adrian G Guggisberg, MD         
Clinique Romande de Readaptation Not yet recruiting
Sion, Switzerland
Contact: José Millan, PhD         
Sponsors and Collaborators
University Hospital, Geneva
Ecole Polytechnique Fédérale de Lausanne
Clinique Romande de Readaptation

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Responsible Party: Adrian Guggisberg, Médecin adjoint agrégé, assistant professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03379532     History of Changes
Other Study ID Numbers: CRSII5-170985B
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases