StrokeRESTORENCT05701280
Pilot/Pivotal Study of DBS+Rehab After Stroke
A study testing Deep Brain Stimulation and Rehabilitation in people with Stroke and Upper Extremity Paresis, run by Enspire DBS Therapy, Inc. at 9 sites in United States.
Trial summary
The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke, Upper Extremity Paresis
- What is being tested?
- Deep Brain Stimulation and Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 9 sitesUnited States
- Study dates
- 3 Feb 2023to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis.
Who cannot join
- Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment
- Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Johns Hopkins School of Medicine
Baltimore, Maryland, 21218
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Cleveland Clinic
Cleveland, Ohio, 44195
NYU Langone Health
New York, New York, 10016
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Barrow Neurological Institute (BNI)
Phoenix, Arizona, 85013
Rhode Island Hospital
Providence, Rhode Island, 02903
Mayo Clinic
Rochester, Minnesota, 55906
About this study
Official title: Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study
The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.
Read the detailed description
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.
- Conditions
- Stroke, Upper Extremity Paresis
- Being tested
- Deep Brain Stimulation, Rehabilitation
- Keywords
- Ischemic Stroke, Deep Brain Stimulation, DBS, Physical Therapy, Rehabilitation, Brain Stimulation
- Medical subject headings
- Stroke, Paresis, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.
RehabilitationOther
Motor rehabilitation to improve upper-extremity function.
| Study group | Role | What they receive |
|---|---|---|
| DBS+Rehab | Experimental | Active-DBS combined with motor rehabilitation Receives: Device: Deep Brain Stimulation |
| Rehab | Active comparator | Control-DBS combined with motor rehabilitation Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
The change in FMA-UE is significantly greater for subjects who receive Test treatment (Tt) than Control treatment (Ct).
Measured: Week-12 to Week-32
Secondary outcomes (1)
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
The change in FMA-UE for subjects who receive Test treatment (Tt) is significantly above a clinically important difference (CID)
Measured: Week-12 to Week-32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start3 Feb 2023
- Primary completionJan 2027 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, randomized, parallel study with partial crossover.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enspire DBS Therapy, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701280
- Sponsor's protocol ID
- REDD 0084
- Acronym
- RESTORE
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study
- ClinicalTrials.gov ID
- NCT05701280
- Acronym / sponsor ID
- RESTORE / REDD 0084
- Conditions
- Stroke, Upper Extremity Paresis
- Keywords
- Ischemic Stroke, Deep Brain Stimulation, DBS, Physical Therapy, Rehabilitation, Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Enspire DBS Therapy, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded, randomized, parallel study with partial crossover.
| Arm | Type | Receives |
|---|---|---|
| DBS+Rehab | Experimental | Device: Deep Brain StimulationActive-DBS combined with motor rehabilitation |
| Rehab | Active comparator | Other: RehabilitationControl-DBS combined with motor rehabilitation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis.
Key exclusion criteria (2 listed)
- Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment
- Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain StimulationDeep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function. | Device | DBS+Rehab |
| RehabilitationMotor rehabilitation to improve upper-extremity function. | Other | Rehab |
Primary outcome
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).
1 secondary outcome
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
Time frame: Week-12 to Week-32
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation and Rehabilitation in people with Stroke and Upper Extremity Paresis, run by Enspire DBS Therapy, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE) (time frame: Week-12 to Week-32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.