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Neurofeedback Training of Alpha-band Coherence After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Neurofeedback training of functional connectivity
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring brain computer interface, neurofeedback, functional connectivity

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Neurorehabilitation, University Hospital of Geneva

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Motor Cortex

Control region

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Fugl Meyer Upper Extremity Motor Assessment Score
Change in Fugl Meyer Upper Extremity Motor Assessment Score from before to after treatment.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 21, 2014
Last Updated
October 27, 2016
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT02223910
Brief Title
Neurofeedback Training of Alpha-band Coherence After Stroke
Official Title
Neurofeedback Training of Alpha-band Coherence After Stroke: a Randomized Controlled Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
brain computer interface, neurofeedback, functional connectivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor Cortex
Arm Type
Active Comparator
Arm Description
Feedback training of functional connectivity between motor cortex and the rest of the brain
Arm Title
Control region
Arm Type
Placebo Comparator
Arm Description
Feedback training of functional connectivity between medial prefrontal cortex of healthy hemisphere and the rest of the brain
Intervention Type
Procedure
Intervention Name(s)
Neurofeedback training of functional connectivity
Primary Outcome Measure Information:
Title
Change in Fugl Meyer Upper Extremity Motor Assessment Score
Description
Change in Fugl Meyer Upper Extremity Motor Assessment Score from before to after treatment.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Change in Fugl Meyer Upper Extremity Motor Assessment Score at 1 month follow up
Description
Change in Fugl Meyer Upper Extremity Motor Assessment Score from before treatment to 1 month after treatment.
Time Frame
8 weeks
Title
Change in compound motor score
Description
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.
Time Frame
4 weeks
Title
Change in compound motor score at follow up
Description
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.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Change in Nine Hole Peg test
Description
Change in Nine Hole Peg test from before treatment to after treatment.
Time Frame
4 weeks
Title
Change in Nine Hole Peg test at follow up
Description
Change in Nine Hole Peg test from before treatment to 4 weeks after treatment.
Time Frame
8 weeks
Title
Change in Motor Activity Log
Description
The Motor Activity Log assessed changes in motor activities of daily living. Change in Nine Hole Peg test from before treatment to after treatment.
Time Frame
4 weeks
Title
Change in Nine Hole Peg at follow up
Description
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.
Time Frame
8 weeks
Title
Change in Spasticity
Description
Change in Modified Ashworth Score from before treatment to after treatment.
Time Frame
4 weeks
Title
Change in Spasticity at follow up
Description
Change in Modified Ashworth Score from before treatment to 4 weeks after treatment.
Time Frame
8 weeks
Title
Change in Medical Research Council (MRC) muscle strength
Description
Change in Medical Research Council (MRC) muscle strength from before treatment to after treatment.
Time Frame
4 weeks
Title
Change in Medical Research Council (MRC) muscle strength at follow up
Description
Change in Medical Research Council (MRC) muscle strength from before treatment to 4 weeks after treatment.
Time Frame
8 weeks
Title
Change in European Stroke Scale
Description
Change in Change in European Stroke Scale from before to after treatment.
Time Frame
4 weeks
Title
Change in Change in European Stroke Scale at follow up
Description
Change in Change in European Stroke Scale from before to 4 weeks after treatment.
Time Frame
8 weeks
Title
Change in walking speed
Description
Change in walking speed as measured with 10m walking test from before to after treatment.
Time Frame
4 weeks
Title
Change in walking speed at follow up
Description
Change in walking speed as measured with 10m walking test from before to 4 weeks after treatment.
Time Frame
8 weeks
Title
Change in timed up and go (TUG) test
Description
Change in timed up and go (TUG) test from before to after treatment.
Time Frame
4 weeks
Title
Change in timed up and go (TUG) test at follow up
Description
Change in timed up and go (TUG) test from before to 4 weeks after treatment.
Time Frame
8 weeks
Title
Change in tactile sensibility
Description
Change in tactile sensibility measured with standardized filaments from before to after treatment.
Time Frame
4 weeks
Title
Change in tactile sensibility at follow up
Description
Change in tactile sensibility measured with standardized filaments from before to 4 weeks after treatment.
Time Frame
8 weeks
Title
Number of Adverse Events
Time Frame
4 weeks
Title
Number of Adverse Events at follow up
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian G Guggisberg, MD
Organizational Affiliation
University of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Neurorehabilitation, University Hospital of Geneva
City
Geneva
State/Province
GE
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
22440653
Citation
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.
Results Reference
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Neurofeedback Training of Alpha-band Coherence After Stroke

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