Trial Outcomes & Findings for Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke (NCT NCT02835443)

Last Updated: 2023-10-13

Results Overview

Incidence of study-related serious adverse events

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

18 Months

Results posted on

2023-10-13

Participant milestones
Measure	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)
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke

Baseline characteristics by cohort
Measure	DBS+Rehab n=12 Participants 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)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

Timeframe: 18 Months

Incidence of study-related serious adverse events

Outcome measures
Measure	DBS+Rehab n=12 Participants This was a single-arm study, and all subjects received Deep Brain Stimulation (DBS) of the dentate nucleus plus rehabilitation therapy (DBS+Rehab).
Adverse Events	0 study-related, serious adverse events

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events
Measure	DBS+Rehab n=12 participants at risk 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)
Blood and lymphatic system disorders Low potassium / hypokalemia (Non Study-Related)	8.3% 1/12 • Number of events 1 • 18 Months

Other adverse events
Measure	DBS+Rehab n=12 participants at risk 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)
Surgical and medical procedures Post-anesthesia nausea	25.0% 3/12 • 18 Months
Surgical and medical procedures Post-surgical incision pain/sensitivity or headache	50.0% 6/12 • 18 Months
Surgical and medical procedures IPG site pain/redness	16.7% 2/12 • 18 Months
Surgical and medical procedures Nausea and vomiting during DBS programming	33.3% 4/12 • 18 Months

Enspire DBS Therapy, Inc.

Phone: 123-456-7890