An interventional study of Deep Brain Stimulation and Rehabilitation in Stroke and Upper Extremity Paresis, sponsored by Enspire DBS Therapy, Inc.. Active, not recruiting at 9 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Enspire DBS Therapy, Inc. · Not applicable, Interventional, and Treatment
Among 1,991 studies in Stroke with a site in United States — 394 open to participants now, 490 under way, 17 of them phase 3. Stroke · United States.
Among the 1,991 studies in Stroke with a site in United States, this one is the 252nd largest by planned enrollment of the 1,617 interventional ones that give a count, is one of 109 that started in 2023, is one of 1,121 with no phase, reaches primary completion later than 183 of the 488 other live ones, and was the 1,570th registered.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 202 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →394 of the 1,991 studies in Stroke with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.
This study: 21 Years and older · all sexes · no healthy volunteers.
The full table on the hub →1,991 studies; the count open now beside each. This study's row is marked.
First in 1980; this study’s year is marked. 109 started in 2023.
Median enrollment 40 across the 1,617 interventional studies, 153 across the 363 observational. Of the 1,327 that completed or were terminated, 561 (42%) have results posted.
295 of 1,991 have an industry lead sponsor. The 10 most frequent:
Enspire DBS Therapy, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Enspire DBS Therapy, Inc. has 2 studies filed under Stroke — fewer than ten, so there is no comparison to draw.
166 of the studies in Stroke with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05065216Phase 3DiaMedica Therapeutics IncTreatment of Acute Ischemic Stroke (ReMEDy2 Trial) | 2026-12 |
| NCT03223220Phase 3Lower Merion Neurology Research FoundationQuelling of Excitotoxicity in Acute Stroke With Ketamine | 2026-12-31 |
| NCT05047172Phase 3University of FloridaComparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis | 2027-01-31 |
| NCT05691244Phase 3Pharmazz, Inc.Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke | 2027-09 |
| NCT05997914University of Massachusetts, WorcesterStorytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation | 2026-11 |
Among the 1,991 studies in Stroke with a site in United States, from their registry updates:
The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
Active-DBS combined with motor rehabilitation
Device: Deep Brain Stimulation
Control-DBS combined with motor rehabilitation
Other: Rehabilitation
Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.
Motor rehabilitation to improve upper-extremity function.
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).
Time frame: Week-12 to Week-32
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)
Time frame: Week-12 to Week-32
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
Exploratory endpoints will be examined for the group originally assigned to Control treatment after crossover.
Time frame: Week-32, Week-40 and Week 52
Started Feb 2023 (actual). Primary completion is estimated for Jan 2027, 47 months after the start.
Of 144 industry-sponsored interventional studies with no phase under Stroke, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 47 months is above that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Enspire DBS Therapy, Inc.