A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device

Stroke Clinical Trial

Official title:

A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02098265
• Other study ID #: 2015-0469
• Secondary ID: A539300SMPH/RADI
• Status: Recruiting
• Phase: N/A
• Start date: June 2010
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: Gemma Gliori, MS
• Phone: 608-262-7269
• Email: ggliori[@]uwhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (Experimental Group):

• Stroke patients with persistent upper extremity (UE) deficits

Inclusion Criteria (Control Group 1)

• Stroke patients without UE impairments

• Participants with risk factors for stroke

• healthy controls

• No known neurologic, psychiatric or developmental disability

Inclusion Criteria (Control Group 2)

• Stroke patients with persistent upper extremity (UE) deficits

• 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

• Pre-stroke independence with a Modified Rankin Score of 0 or 1, for the standard FES only intervention.

Exclusion Criteria (for all participants):

• Allergic to electrode gel, surgical tape and metals

• Participants under treatment for infectious diseases or having apparent oral lesions or inflammation will be excluded from the study

• Women who are pregnant or may become pregnant during the course of the study will be excluded

• Participants with contraindications for MRI will be offered the opportunity to participate in the interventions study only (e.g. EEG-BCI-FES and behavioral testing)

Exclusion Criteria (for healthy controls)

• Contraindications for MRI

• Allergic to electrode gel, surgical tape, and metals.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Functional Electric Stimulation (FES)
FES uses low energy electrical pulses to artificially generate body movements in individuals with muscle paralysis. FES can be used to generate muscle contraction in otherwise paralyzed limbs to restore function.

Behavioral:
• Behavioral Assessments
These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.

Other:
• Magnetic Resonance Imaging
A functional magnetic resonance image will be collected.
• EEG
EEG electrodes will be attached to the participant's scalp using a standard, commercially available electrode cap. Proper electrode placement is made according to the international 10-20 system, ensuring complete electrode coverage over sensorimotor cortex.
• RecoveriX
RecoveriX is a brain driven rehabilitation system for stroke patients that pairs mental activities with motor functions.
• Delay
10 week delay before intervention

Device:
• BCI-FES

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Action Research Arm Test Scores	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)	4 months
Secondary	Change in Electroencephalogram (EEG) Response Strength	The change in the strength of the EEG response before and after functional stimulation during left arm imagery with respect to right arm imagery.	4 months
Secondary	Signal change in functional MRI	To compare the percent signal change in the functional MRI activations before and after functional stimulation.	4 months

External Links

•   Publication resulting from this work.
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•   Publication resulting from this work.
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•   Publication resulting from this work.