Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-30 @ 3:03 AM
Study NCT ID:
NCT05601661
Status:
COMPLETED
Last Update Posted:
2025-10-28
First Post:
2022-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Feasibility of Paired Vagus Nerve Stimulation With Rehabilitation for Improving Upper Extremity Function in People With Cervical Spinal Cord Injury
Sponsor:
The University of Texas Health Science Center, Houston
Organization:
Study Overview
Official Title:
Safety and Feasibility of Paired Vagus Nerve Stimulation With Rehabilitation for Improving Upper Extremity Function in People With Cervical Spinal Cord Injury: A Pilot Randomized Control Trial.
Status:
COMPLETED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the safety and feasibility of pairing vagus nerve stimulation (VNS) with rehabilitation and to determine the efficacy of pairing VNS with rehabilitation.
Detailed Description:
The current study will evaluate the safety and feasibility of a novel rehabilitation protocol to improve upper limb motor recovery in adults with incomplete cervical SCI. In this double-blinded, randomized, placebo-controlled pilot trial, 8 adults (above 18 years) with cervical SCI will be randomly assigned in a 1:1 ratio to active VNS paired with rehabilitation or control VNS paired with rehabilitation. All participants will be implanted with a VNS device and randomized to receive either active VNS (0.8mA) or control VNS (0.0 mA) paired with upper limb rehabilitation. All participants will receive three 1.5-hour sessions per week for 6 weeks of in-clinic therapy, followed by a daily, 30 minutes home therapy program for 90 days. The rehabilitation therapy involves repetitive, progressive, task-specific exercises adjusted to the participant's functional level. Participants, assessors, and therapists will maintain blinding until the completion of this phase. After 90 days, in phase II, participants in the control VNS group will cross over to receive active VNS paired with rehabilitation. Safety and feasibility measures are the primary outcomes of this study. Safety measures will include the incidence of surgical and VNS therapy-related events. Feasibility metrics include reporting attrition rate and compliance rate with both in-clinic therapy sessions and home exercise programs. To measure efficacy, change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension from baseline to immediately after 6-week in-clinic treatment and 90-day assessment will be analyzed. Additional clinical outcomes include the Toronto Rehab Institute Hand Function Test, Capabilities of Upper Extremity Questionnaire, spinal cord injury independence self-care measure, and spinal cord injury quality of life. The results of this study will provide valuable information on safety and feasibility and insight into the efficacy of pairing VNS with rehabilitation in people with SCI. Knowledge obtained from this study will lay the groundwork for future large randomized control trials to assess the dosing and effectiveness of pairing VNS with rehabilitation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: