Pilot/Pivotal Study of DBS+Rehab After Stroke

Description

The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.

Conditions

Stroke, Upper Extremity Paresis

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Study Overview

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Study Details

Study overview

The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.

Rehab with Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): a Pivotal Study

Pilot/Pivotal Study of DBS+Rehab After Stroke

Condition
Stroke
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55906

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Providence

Rhode Island Hospital, Providence, Rhode Island, United States, 02903

Charleston

Medical University of South Carolina (MUSC), Charleston, South Carolina, United States, 29425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis.
  • * Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment
  • * Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Enspire DBS Therapy, Inc.,

Study Record Dates

2030-06