N/A
N=12
Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02835443 ↗Enrolled (actual)
12
Serious AEs
8.3%
Results posted
Oct 2023
Primary outcome: Primary: Adverse Events — 0 study-related, serious adverse events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Deep Brain Stimulation (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Enspire DBS Therapy, Inc.
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
— | — |
Summary
This clinical trial will evaluate if Deep Brain Stimulation (DBS) is safe for the treatment of stroke and will help understand if DBS improves motor recovery for patients who continue to have significant impairment.
Eligibility Criteria
Key Inclusion Criteria
- One-time stroke that occurred 1-3 years ago (i.e. index stroke 12-36 months)
- Stroke due to a blocked blood vessel (i.e. unilateral MCA stroke)
- Moderate to severe weakness in one arm (i.e. unilateral upper-extremity hemiparesis)
Key Exclusion Criteria
- Seizures since time of stroke (i.e. seizures or seizure disorder)
- Unable to have an MRI (i.e. contraindicated for MRI)
Data sourced from ClinicalTrials.gov (NCT02835443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.