Overview

This trial has been completed.

Condition stroke
Treatment neurofeedback training of functional connectivity
Sponsor University Hospital, Geneva
Start date February 2014
End date June 2016
Trial size 13 participants
Trial identifier NCT02223910, NAC 10-075

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Feedback training of functional connectivity between motor cortex and the rest of the brain
neurofeedback training of functional connectivity
(Placebo Comparator)
Feedback training of functional connectivity between medial prefrontal cortex of healthy hemisphere and the rest of the brain
neurofeedback training of functional connectivity

Primary Outcomes

Measure
Change in Fugl Meyer Upper Extremity Motor Assessment Score
time frame: Week 4

Secondary Outcomes

Measure
Change in Fugl Meyer Upper Extremity Motor Assessment Score at 1 month follow up
time frame: 8 weeks
Change in compound motor score
time frame: 4 weeks
Change in compound motor score at follow up
time frame: 8 weeks

Eligibility Criteria

Male or female participants at least 16 years old.

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

Additional Information

Official title Neurofeedback Training of Alpha-band Coherence After Stroke: a Randomized Controlled Crossover Trial
Principal investigator Adrian G Guggisberg, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University Hospital, Geneva.