- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02223910
Neurofeedback Training of Alpha-band Coherence After Stroke
Neurofeedback Training of Alpha-band Coherence After Stroke: a Randomized Controlled Crossover Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
GE
-
Geneva, GE, Switzerland, 1211
- Division of Neurorehabilitation, University Hospital of Geneva
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Motor Cortex
Feedback training of functional connectivity between motor cortex and the rest of the brain
|
|
Placebo Comparator: Control region
Feedback training of functional connectivity between medial prefrontal cortex of healthy hemisphere and the rest of the brain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks
|
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.
|
4 weeks
|
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.
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Nine Hole Peg test
Time Frame: 4 weeks
|
Change in Nine Hole Peg test from before treatment to after treatment.
|
4 weeks
|
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.
|
8 weeks
|
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 weeks
|
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.
|
8 weeks
|
Change in Spasticity
Time Frame: 4 weeks
|
Change in Modified Ashworth Score from before treatment to after treatment.
|
4 weeks
|
Change in Spasticity at follow up
Time Frame: 8 weeks
|
Change in Modified Ashworth Score from before treatment to 4 weeks after treatment.
|
8 weeks
|
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.
|
4 weeks
|
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.
|
8 weeks
|
Change in European Stroke Scale
Time Frame: 4 weeks
|
Change in Change in European Stroke Scale from before to after treatment.
|
4 weeks
|
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.
|
8 weeks
|
Change in walking speed
Time Frame: 4 weeks
|
Change in walking speed as measured with 10m walking test from before to after treatment.
|
4 weeks
|
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.
|
8 weeks
|
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.
|
4 weeks
|
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.
|
8 weeks
|
Change in tactile sensibility
Time Frame: 4 weeks
|
Change in tactile sensibility measured with standardized filaments from before to after treatment.
|
4 weeks
|
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.
|
8 weeks
|
Number of Adverse Events
Time Frame: 4 weeks
|
4 weeks
|
|
Number of Adverse Events at follow up
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adrian G Guggisberg, MD, University of Geneva
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NAC 10-075
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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