Stroke
Conditions
Keywords
Ischemic Stroke, Deep Brain Stimulation, DBS, Physical Therapy, Rehab, Brain Stimulation
Brief 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.
Detailed description
The proposed study is a safety and feasibility study intended to provide preliminary data to design a future pilot study. The objective of this study is to document the safety and patient outcomes of electrical stimulation of the dentate nucleus area for the management of chronic, moderate to severe upper extremity hemiparesis due to ischemic stroke.
Interventions
DEVICEDeep Brain Stimulation
Electrical stimulation of the dentate nucleus area of the cerebellum.
Sponsors
Enspire DBS Therapy, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 18 Months | Incidence of study-related serious adverse events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DBS+Rehab This was a single-arm study, and all subjects received Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus rehab (DBS+Rehab) | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | DBS+Rehab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 9 / 12 |
| serious Total, serious adverse events | 1 / 12 |
Outcome results
Primary
Adverse Events
Incidence of study-related serious adverse events
Time frame: 18 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DBS+Rehab | Adverse Events | 0 study-related, serious adverse events |