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Neurofeedback Training of Alpha-band Coherence After Stroke

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ClinicalTrials.gov Identifier: NCT02223910
Recruitment Status : Completed
First Posted : August 22, 2014
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Adrian Guggisberg, University Hospital, Geneva

Brief Summary:

Background: The technology of brain-computer interfaces (BCI) enables the monitoring of brain activity and the generation of a real-time output about specific changes in activity patterns. The recorded subject receives a feedback about the neural activity associated his/her efforts and can thus learn to voluntarily modulate brain activity. There is accumulating evidence that training of motor cortex activations with brain-computer interface systems can enhance recovery in stroke patients. Here we propose a new approach which trains resting-state correlates of motor performance instead of activations related to movements. Previous studies have shown that the more resting-state alpha oscillations in the motor cortex are coherent with the rest of the brain, the better stroke patients perform in motor tasks. Furthermore, observational studies have suggested that training of alpha-band coherence in the motor cortex with neurofeedback has beneficial effects on motor performance.

Objective : This randomized controlled study aims to test the usefulness of training functional connectivity between the motor cortex and the rest of the brain with a brain-computer interface in patients with chronic stroke. We hypothesized that this network variant of neurofeedback training will lead to region and frequency specific increases in functional connectivity and to an improved function of the affected upper extremity.

Methods : 10 patients with chronic stroke and significant unilateral deficit of upper extremity motor function will perform two periods of neurofeedback training in a randomized cross-over design. In one period, they will train alpha-band coherence between intact areas around the affected motor cortex and the rest of the brain. In a control period, they will train alpha-band coherence between a control region not directly related to motor function (the medial prefrontal cortex of the healthy hemisphere) and the rest of the brain. In each period, two training sessions per week will be performed for 4 weeks. The periods are separated by at least 4 weeks. Oscillations in the brain will be reconstructed from 128 EEG channels using an adaptive spatial filter and the coherence between the target area and the rest of the brain will be calculated in real time. Coherence magnitude will be displayed in the form of a cursor on a computer screen.

Significance: This study may provide causal evidence for a role of functional connectivity in motor learning and may lead to new strategies for rehabilitation.


Condition or disease Intervention/treatment Phase
Stroke Procedure: Neurofeedback training of functional connectivity Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neurofeedback Training of Alpha-band Coherence After Stroke: a Randomized Controlled Crossover Trial
Study Start Date : February 2014
Actual Primary Completion Date : June 2016

Arm Intervention/treatment
Active Comparator: Motor Cortex
Feedback training of functional connectivity between motor cortex and the rest of the brain
Procedure: Neurofeedback training of functional connectivity
Placebo Comparator: Control region
Feedback training of functional connectivity between medial prefrontal cortex of healthy hemisphere and the rest of the brain
Procedure: Neurofeedback training of functional connectivity



Primary Outcome Measures :
  1. Change in Fugl Meyer Upper Extremity Motor Assessment Score [ Time Frame: Week 4 ]
    Change in Fugl Meyer Upper Extremity Motor Assessment Score from before to after treatment.


Secondary Outcome Measures :
  1. Change in Fugl Meyer Upper Extremity Motor Assessment Score at 1 month follow up [ Time Frame: 8 weeks ]
    Change in Fugl Meyer Upper Extremity Motor Assessment Score from before treatment to 1 month after treatment.

  2. Change in compound motor score [ Time Frame: 4 weeks ]
    For calculation of the compound motor score, the Fugl Meyer Upper Extremity Motor Assessment, the Nine Hole Peg test, and the Jamar Dynamometer assessment are each normalized to values and then averaged. Change is computed as difference from before treatment to after treatment.

  3. Change in compound motor score at follow up [ Time Frame: 8 weeks ]
    For calculation of the compound motor score, the Fugl Meyer Upper Extremity Motor Assessment, the Nine Hole Peg test, and the Jamar Dynamometer assessment are each normalized to values and then averaged. Change is computed as difference from before treatment to 4 weeks after treatment.


Other Outcome Measures:
  1. Change in Nine Hole Peg test [ Time Frame: 4 weeks ]
    Change in Nine Hole Peg test from before treatment to after treatment.

  2. Change in Nine Hole Peg test at follow up [ Time Frame: 8 weeks ]
    Change in Nine Hole Peg test from before treatment to 4 weeks after treatment.

  3. Change in Motor Activity Log [ Time Frame: 4 weeks ]
    The Motor Activity Log assessed changes in motor activities of daily living. Change in Nine Hole Peg test from before treatment to after treatment.

  4. Change in Nine Hole Peg at follow up [ Time Frame: 8 weeks ]
    The Motor Activity Log assessed changes in motor activities of daily living. Change in Nine Hole Peg test from before treatment to 4 weeks after treatment.

  5. Change in Spasticity [ Time Frame: 4 weeks ]
    Change in Modified Ashworth Score from before treatment to after treatment.

  6. Change in Spasticity at follow up [ Time Frame: 8 weeks ]
    Change in Modified Ashworth Score from before treatment to 4 weeks after treatment.

  7. Change in Medical Research Council (MRC) muscle strength [ Time Frame: 4 weeks ]
    Change in Medical Research Council (MRC) muscle strength from before treatment to after treatment.

  8. Change in Medical Research Council (MRC) muscle strength at follow up [ Time Frame: 8 weeks ]
    Change in Medical Research Council (MRC) muscle strength from before treatment to 4 weeks after treatment.

  9. Change in European Stroke Scale [ Time Frame: 4 weeks ]
    Change in Change in European Stroke Scale from before to after treatment.

  10. Change in Change in European Stroke Scale at follow up [ Time Frame: 8 weeks ]
    Change in Change in European Stroke Scale from before to 4 weeks after treatment.

  11. Change in walking speed [ Time Frame: 4 weeks ]
    Change in walking speed as measured with 10m walking test from before to after treatment.

  12. Change in walking speed at follow up [ Time Frame: 8 weeks ]
    Change in walking speed as measured with 10m walking test from before to 4 weeks after treatment.

  13. Change in timed up and go (TUG) test [ Time Frame: 4 weeks ]
    Change in timed up and go (TUG) test from before to after treatment.

  14. Change in timed up and go (TUG) test at follow up [ Time Frame: 8 weeks ]
    Change in timed up and go (TUG) test from before to 4 weeks after treatment.

  15. Change in tactile sensibility [ Time Frame: 4 weeks ]
    Change in tactile sensibility measured with standardized filaments from before to after treatment.

  16. Change in tactile sensibility at follow up [ Time Frame: 8 weeks ]
    Change in tactile sensibility measured with standardized filaments from before to 4 weeks after treatment.

  17. Number of Adverse Events [ Time Frame: 4 weeks ]
  18. Number of Adverse Events at follow up [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ischemic or hemorrhagic stroke in chronic stage (at least 9 months after onset)
  • unilateral deficits in motor function with significant impact on independence and daily activities

Exclusion Criteria:

  • inability to participate in long treatment sessions
  • inability to concentrate for prolonged periods
  • metallic objects in the brain
  • presence of implants or neural stimulators
  • persistent delirium or disturbed vigilance
  • moderate or severe language comprehension deficits
  • skull breach
  • new stroke lesions during treatment
  • medical complications

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): NCT02223910


Locations
Switzerland
Division of Neurorehabilitation, University Hospital of Geneva
Geneva, GE, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Adrian G Guggisberg, MD University of Geneva

Publications:
Responsible Party: Adrian Guggisberg, Médecin adjoint agrégé, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02223910     History of Changes
Other Study ID Numbers: NAC 10-075
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016

Keywords provided by Adrian Guggisberg, University Hospital, Geneva:
brain computer interface
neurofeedback
functional connectivity

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