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Completed

NCT Number: NCT02223910

Neurofeedback Training of Alpha-band Coherence After Stroke

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Neurorehabilitation, University Hospital of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurofeedback training of functional connectivity

Procedure

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
First posted
Aug 22, 2014
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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