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NCT Number: NCT05701280

Pilot/Pivotal Study of DBS+Rehab After Stroke

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Upper Extremity Paresis Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barrow Neurological Institute (BNI), Phoenix, Arizona, United States

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About this study

The RESTORE Stroke Study combines two phases of study under one protocol (pilot/pivotal). The first phase has a sample size of 40 subjects. The second phase has an estimated sample size of 162 subjects which may be adjusted based on analysis of the first phase.

Each subject will be implanted with the DBS system, undergo DBS program optimization, and be randomized to test treatment (Tt) or active-control treatment (Ct). After randomization, all subjects will participate in a five-month outpatient rehabilitation therapy program. After five months of blinded randomized testing, subjects assigned to active-control treatment (Ct) will cross over to receive test treatment (Tt) and participate in a second five-month therapy program.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep brain stimulation

Device

Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.

rehabilitation

Other

Motor rehabilitation to improve upper-extremity function.

Primary outcomes

  1. Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)

    Time frame: Week-12 to Week-32

    The change in FMA-UE is significantly greater for subjects who receive Test treatment (Tt) than Control treatment (Ct).

Secondary outcomes

  1. Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)

    Time frame: Week-12 to Week-32

    The change in FMA-UE for subjects who receive Test treatment (Tt) is significantly above a clinically important difference (CID)

Other outcomes

  1. Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)

    Time frame: Week-32, Week-40 and Week 52

    Exploratory endpoints will be examined for the group originally assigned to Control treatment after crossover.

Sponsors and collaborators

Lead sponsor

Enspire DBS Therapy, Inc.

Industry

Registry information

Official study title

Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study

Acronym: RESTORE

Important dates

Study start
2023
Primary completion
2027
Study completion
2030
First posted
Jan 27, 2023
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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