Neurofeedback Training of Alpha-band Coherence After Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223910
• Other study ID #: NAC 10-075
• Status: Completed
• Phase: N/A
• First received: August 21, 2014
• Last updated: October 27, 2016
• Start date: February 2014

Study information

• Verified date: October 2016
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• Neurofeedback training of functional connectivity

Locations

Country	Name	City	State
Switzerland	Division of Neurorehabilitation, University Hospital of Geneva	Geneva	GE

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Nine Hole Peg test	Change in Nine Hole Peg test from before treatment to after treatment.	4 weeks	No
Other	Change in Nine Hole Peg test at follow up	Change in Nine Hole Peg test from before treatment to 4 weeks after treatment.	8 weeks	No
Other	Change in Motor Activity Log	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	No
Other	Change in Nine Hole Peg at follow up	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	No
Other	Change in Spasticity	Change in Modified Ashworth Score from before treatment to after treatment.	4 weeks	No
Other	Change in Spasticity at follow up	Change in Modified Ashworth Score from before treatment to 4 weeks after treatment.	8 weeks	No
Other	Change in Medical Research Council (MRC) muscle strength	Change in Medical Research Council (MRC) muscle strength from before treatment to after treatment.	4 weeks	No
Other	Change in Medical Research Council (MRC) muscle strength at follow up	Change in Medical Research Council (MRC) muscle strength from before treatment to 4 weeks after treatment.	8 weeks	No
Other	Change in European Stroke Scale	Change in Change in European Stroke Scale from before to after treatment.	4 weeks	No
Other	Change in Change in European Stroke Scale at follow up	Change in Change in European Stroke Scale from before to 4 weeks after treatment.	8 weeks	No
Other	Change in walking speed	Change in walking speed as measured with 10m walking test from before to after treatment.	4 weeks	No
Other	Change in walking speed at follow up	Change in walking speed as measured with 10m walking test from before to 4 weeks after treatment.	8 weeks	No
Other	Change in timed up and go (TUG) test	Change in timed up and go (TUG) test from before to after treatment.	4 weeks	No
Other	Change in timed up and go (TUG) test at follow up	Change in timed up and go (TUG) test from before to 4 weeks after treatment.	8 weeks	No
Other	Change in tactile sensibility	Change in tactile sensibility measured with standardized filaments from before to after treatment.	4 weeks	No
Other	Change in tactile sensibility at follow up	Change in tactile sensibility measured with standardized filaments from before to 4 weeks after treatment.	8 weeks	No
Other	Number of Adverse Events		4 weeks	Yes
Other	Number of Adverse Events at follow up		8 weeks	Yes
Primary	Change in Fugl Meyer Upper Extremity Motor Assessment Score	Change in Fugl Meyer Upper Extremity Motor Assessment Score from before to after treatment.	Week 4	No
Secondary	Change in Fugl Meyer Upper Extremity Motor Assessment Score at 1 month follow up	Change in Fugl Meyer Upper Extremity Motor Assessment Score from before treatment to 1 month after treatment.	8 weeks	No
Secondary	Change in compound motor score	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	No
Secondary	Change in compound motor score at follow up	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	No