RecruitingNot ApplicableNCT02098265

A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device

Sponsor

University of Wisconsin, Madison

Enrollment

288 participants

Start Date

Jun 1, 2010

Study Type

INTERVENTIONAL

Conditions

Stroke

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

Stroke patients with persistent upper extremity (UE) deficits
Stroke patients without UE impairments
Participants with risk factors for stroke
healthy controls
No known neurologic, psychiatric or developmental disability
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 Criteria6

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)
Contraindications for MRI
Allergic to electrode gel, surgical tape, and metals.

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Interventions

DEVICEFunctional 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.

BEHAVIORALBehavioral Assessments

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

OTHERMagnetic Resonance Imaging

A functional magnetic resonance image will be collected.

OTHEREEG

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.

OTHERRecoveriX

RecoveriX is a brain driven rehabilitation system for stroke patients that pairs mental activities with motor functions.

OTHERDelay

10 week delay before intervention

DEVICEBCI-FES