A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Behavioral: Behavioral Assessments; Other: RecoveriX; Device: Functional Electric Stimulation (FES); Other: Magnetic Resonance Imaging; Other: EEG; Other: Delay; Device: BCI-FES

• Registration Number: NCT02098265
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

The purpose of this research is to determine if two non-invasive brain stimulation techniques, muscle stimulation of the arm and neuro-stimulation through the tongue, can increase the extent of stroke recovery.

Detailed Description

The aim of this study is to determine if functional muscle stimulation, in addition to non-invasive neurostimulation through the tongue (TDU), directed by electroencephalogram (EEG) output, can increase the extent of stroke recovery on behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI).

Adult stroke patients with upper extremity motor impairments (henceforth "experimental group"), healthy controls, and participants with risk factors for stroke, without upper extremity impairment (allowing them to serve as controls for patients with upper extremity impairments (henceforth "control group")), will be recruited in this study. Half of the participants in the experimental group will be randomly assigned to the EEG-BCI (brain-computer interface) training ("closed-loop") group and will receive training on the BCI task along with muscle and tongue stimulation. The other half of the participants in the experimental group receiving traditional rehab will not receive any kind of FES or tongue stimulation for the first 8-10 weeks of study period and then will start receiving BCI-FES-tongue stimulation rehab therapy.

All participants without UE impairment in Control group 1 will receive 4-6 (minimum 4, up to a maximum of 6) sessions of training on the BCI system and pre- and post MRI and 2 behavioral testing sessions.

Addition of a Control group 2 is consistent with the AHA grants - Twenty four ischemic stroke patients with moderate upper extremity (dominant right hand affected) impairment (score of 1 or 2 on the motor sub-component of the NIH stroke scale (NIHSS) and ARAT score 20-45); no upper extremity injury or conditions that limited use prior to the stroke; and pre-stroke independence with a Modified Rankin Score of 0 or 1), will be recruited in this arm. All participants in this group will receive MR sessions and behavioral testing similar to the Experimental group.

Addition of an Experimental group receiving EEG-BCI-bilateral FES intervention using the recoveriX system: recoveriX is a brain driven rehabilitation system for stroke patients that pairs mental activities with motor functions. Through the EEG-based recoveriX BCI system, the brain receives visual and tactile feedback in real-time, making rehabilitation more effective. A stroke patient imagines a hand movement while receiving visual feedback through a virtual avatar, and tactile feedback through electrical muscle stimulation paired to the patient's imagined movement, with the aim that these patients might regain the volitional ability to grasp following therapy. Unlike the current EEG-BCI-FES intervention that involves stimulation of only the impaired arm, with recoveriX, both arms are simultaneously stimulated during the course of the intervention.

Specific Aims

To determine if functional muscle stimulation of the arms, in addition to non-invasive neurostimulation through the tongue (TDU), directed by electroencephalogram (EEG) output, can increase the extent of stroke recovery as measured by behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI).

Primary objective

* To examine the effect of EEG guided functional muscle stimulation on improvement in upper extremity function

Secondary objective

* To examine plasticity changes as measured by EEG/fMRI measures before and after EEG guided functional muscle stimulation.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-24
• Study First Posted: 2014-03-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group - Immediate BCI Therapy	Behavioral Assessments	EEG - BCI training (closed loop)
Experimental Group - Delayed BCI Therapy	Delay	Scanned and tested 4 times over a 10-week period before EEG-BCI training
Experimental Group - Delayed BCI Therapy	BCI-FES	Scanned and tested 4 times over a 10-week period before EEG-BCI training
Experimental Group - Delayed BCI Therapy	Magnetic Resonance Imaging	Scanned and tested 4 times over a 10-week period before EEG-BCI training
Experimental Group - Immediate BCI Therapy	Magnetic Resonance Imaging	EEG - BCI training (closed loop)
Experimental Group - Immediate BCI Therapy	EEG	EEG - BCI training (closed loop)
Experimental Group - Immediate BCI Therapy	BCI-FES	EEG - BCI training (closed loop)
Experimental Group - Delayed BCI Therapy	Behavioral Assessments	Scanned and tested 4 times over a 10-week period before EEG-BCI training
Experimental Group - Delayed BCI Therapy	EEG	Scanned and tested 4 times over a 10-week period before EEG-BCI training
Control Group 1	BCI-FES	48 stroke patients, 48 participants with risk factors for stroke, 48 healthy controls receiving 4-6 training sessions on the EEG-BCI, pre- and post- behavioral testing, and MRI
Experimental Group - RecoveriX	RecoveriX	Recruited from participants who have completed the study intervention
Control Group 1	EEG	48 stroke patients, 48 participants with risk factors for stroke, 48 healthy controls receiving 4-6 training sessions on the EEG-BCI, pre- and post- behavioral testing, and MRI
Control Group 2	Functional Electric Stimulation (FES)	24 Stroke Patients with UE impairment receiving standard FES only therapy
Control Group 1	Behavioral Assessments	48 stroke patients, 48 participants with risk factors for stroke, 48 healthy controls receiving 4-6 training sessions on the EEG-BCI, pre- and post- behavioral testing, and MRI
Control Group 1	Magnetic Resonance Imaging	48 stroke patients, 48 participants with risk factors for stroke, 48 healthy controls receiving 4-6 training sessions on the EEG-BCI, pre- and post- behavioral testing, and MRI

Primary Outcome Measures

Name	Time	Method
Action Research Arm Test Scores	4 months	The Action Research Arm Test (ARAT) is designed for evaluation of upper extremity function. This test consists of sections for Grasp, Grip, Pinch and Gross Movements and comprise a total of 19 tests. Each test is scored 0-3 where 0 is 'no movement' and 3 is 'the movement is performed normally'. Each section is scored separately and the scores added for a total possible range of scores from 0-57 where the higher the score, the complete and efficient the movement. ARAT will be assessed at baseline and end of study (approximately 4 months)

Secondary Outcome Measures

Name	Time	Method
Signal change in functional MRI	4 months	To compare the percent signal change in the functional MRI activations before and after functional stimulation.
Change in Electroencephalogram (EEG) Response Strength	4 months	The change in the strength of the EEG response before and after functional stimulation during left arm imagery with respect to right arm imagery.

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States