Clinical trial NCT02223910: Neurofeedback Training of Alpha-band Coherence After Stroke
Official title: Neurofeedback Training of Alpha-band Coherence After Stroke: a Randomized Controlled Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: brain computer interface
neurofeedback
functional connectivity
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2014-08-22
Enrollment: 13
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Fugl Meyer Upper Extremity Motor Assessment Score
timeFrame: Week 4
Secondary outcomes:
measure: Change in Fugl Meyer Upper Extremity Motor Assessment Score at 1 month follow up
timeFrame: 8 weeks
measure: Change in compound motor score
timeFrame: 4 weeks
measure: Change in compound motor score at follow up
timeFrame: 8 weeks
Other outcomes:
measure: Change in Nine Hole Peg test
timeFrame: 4 weeks
measure: Change in Nine Hole Peg test at follow up
timeFrame: 8 weeks
measure: Change in Motor Activity Log
timeFrame: 4 weeks
measure: Change in Nine Hole Peg at follow up
timeFrame: 8 weeks
measure: Change in Spasticity
timeFrame: 4 weeks
measure: Change in Spasticity at follow up
timeFrame: 8 weeks
measure: Change in Medical Research Council (MRC) muscle strength
timeFrame: 4 weeks
measure: Change in Medical Research Council (MRC) muscle strength at follow up
timeFrame: 8 weeks
measure: Change in European Stroke Scale
timeFrame: 4 weeks
measure: Change in Change in European Stroke Scale at follow up
timeFrame: 8 weeks
measure: Change in walking speed
timeFrame: 4 weeks
measure: Change in walking speed at follow up
timeFrame: 8 weeks
measure: Change in timed up and go (TUG) test
timeFrame: 4 weeks
measure: Change in timed up and go (TUG) test at follow up
timeFrame: 8 weeks
measure: Change in tactile sensibility
timeFrame: 4 weeks
measure: Change in tactile sensibility at follow up
timeFrame: 8 weeks
measure: Number of Adverse Events
timeFrame: 4 weeks
measure: Number of Adverse Events at follow up
timeFrame: 8 weeks
Locations:
city: Geneva
country: Switzerland
facility: Division of Neurorehabilitation, University Hospital of Geneva
state: GE
Study officials:
affiliation: University of Geneva
name: Adrian G Guggisberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dubovik S, Pignat JM, Ptak R, Aboulafia T, Allet L, Gillabert N, Magnin C, Albert F, Momjian-Mayor I, Nahum L, Lascano AM, Michel CM, Schnider A, Guggisberg AG. The behavioral significance of coherent resting-state oscillations after stroke. Neuroimage. 2012 May 15;61(1):249-57. doi: 10.1016/j.neuroimage.2012.03.024. Epub 2012 Mar 13.