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Neurofeedback Training of Alpha-band Coherence After Stroke

Neurofeedback Training of Alpha-band Coherence After Stroke: a Randomized Controlled Crossover Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02223910
Enrollment
13
Registered
2014-08-22
Start date
2014-02-28
Completion date
Unknown
Last updated
2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

brain computer interface, neurofeedback, functional connectivity

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.

Interventions

PROCEDURENeurofeedback training of functional connectivity

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Fugl Meyer Upper Extremity Motor Assessment ScoreWeek 4Change in Fugl Meyer Upper Extremity Motor Assessment Score from before to after treatment.

Secondary

MeasureTime frameDescription
Change in Fugl Meyer Upper Extremity Motor Assessment Score at 1 month follow up8 weeksChange in Fugl Meyer Upper Extremity Motor Assessment Score from before treatment to 1 month after treatment.
Change in compound motor score4 weeksFor 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.
Change in compound motor score at follow up8 weeksFor 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

MeasureTime frameDescription
Change in Spasticity4 weeksChange in Modified Ashworth Score from before treatment to after treatment.
Change in Spasticity at follow up8 weeksChange in Modified Ashworth Score from before treatment to 4 weeks after treatment.
Change in Medical Research Council (MRC) muscle strength4 weeksChange in Medical Research Council (MRC) muscle strength from before treatment to after treatment.
Change in Medical Research Council (MRC) muscle strength at follow up8 weeksChange in Medical Research Council (MRC) muscle strength from before treatment to 4 weeks after treatment.
Change in European Stroke Scale4 weeksChange in Change in European Stroke Scale from before to after treatment.
Change in Change in European Stroke Scale at follow up8 weeksChange in Change in European Stroke Scale from before to 4 weeks after treatment.
Change in walking speed4 weeksChange in walking speed as measured with 10m walking test from before to after treatment.
Change in Nine Hole Peg test4 weeksChange in Nine Hole Peg test from before treatment to after treatment.
Change in timed up and go (TUG) test4 weeksChange in timed up and go (TUG) test from before to after treatment.
Change in timed up and go (TUG) test at follow up8 weeksChange in timed up and go (TUG) test from before to 4 weeks after treatment.
Change in tactile sensibility4 weeksChange in tactile sensibility measured with standardized filaments from before to after treatment.
Change in tactile sensibility at follow up8 weeksChange in tactile sensibility measured with standardized filaments from before to 4 weeks after treatment.
Number of Adverse Events4 weeks
Number of Adverse Events at follow up8 weeks
Change in walking speed at follow up8 weeksChange in walking speed as measured with 10m walking test from before to 4 weeks after treatment.
Change in Nine Hole Peg test at follow up8 weeksChange in Nine Hole Peg test from before treatment to 4 weeks after treatment.
Change in Motor Activity Log4 weeksThe Motor Activity Log assessed changes in motor activities of daily living. Change in Nine Hole Peg test from before treatment to after treatment.
Change in Nine Hole Peg at follow up8 weeksThe 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026