Pilot/Pivotal Study of DBS+Rehab After Stroke

Launched by ENSPIRE DBS THERAPY, INC. · Jan 17, 2023

Keywords

ClinConnect Summary

The RESTORE Stroke Study is examining a new treatment approach that combines deep brain stimulation (DBS) with rehabilitation (rehab) to help people who have experienced a stroke regain strength and function in their arms. This study is looking for individuals who are between 70 and 90 years old and have had an ischemic stroke (a type of stroke caused by a blockage of blood flow to the brain) within the last 12 months to 6 years. Eligible participants should have some weakness or difficulty using their arm as a result of the stroke.

If you or a loved one qualifies for this study, you can expect to receive DBS treatment along with specialized rehabilitation to improve arm movement and function. The study is currently recruiting participants, and it's important to note that those with certain brain injuries or previous strokes affecting the arms may not be eligible. This trial aims to determine how safe and effective this combined treatment is, potentially offering new hope for recovery after a stroke.

Gender

ALL

Eligibility criteria

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