Neurofeedback Training of Alpha-band Coherence After Stroke

NCT02223910 | Completed

• 1 other identifier: NAC 10-075
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

brain computer interface; neurofeedback; functional connectivity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change in Fugl Meyer Upper Extremity Motor Assessment Score at 1 month follow up

  8 weeks

• Change in compound motor score

  4 weeks

• Change in compound motor score at follow up

  8 weeks

Other Outcomes (18)

• Change in Nine Hole Peg test

  4 weeks

• Change in Nine Hole Peg test at follow up

  8 weeks

• Change in Motor Activity Log

  4 weeks

Study Arms (2)

Motor Cortex

ACTIVE COMPARATOR

Feedback training of functional connectivity between motor cortex and the rest of the brain

Procedure: Neurofeedback training of functional connectivity

Control region

PLACEBO COMPARATOR

Feedback training of functional connectivity between medial prefrontal cortex of healthy hemisphere and the rest of the brain

Procedure: Neurofeedback training of functional connectivity

Interventions

Neurofeedback training of functional connectivity PROCEDURE

Control region; Motor Cortex

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Division of Neurorehabilitation, University Hospital of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related 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.

  PMID: 22440653 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Adrian G Guggisberg, MD

  University of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Médecin adjoint agrégé

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 22, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2016
• Last Updated: October 31, 2016

Record last verified: 2016-10

Locations

CH (1)