search
Back to results

Safety and Feasibility of Paired Vagus Nerve Stimulation With Rehabilitation for Improving Upper Extremity Function in People With Cervical Spinal Cord Injury

Primary Purpose

Cervical Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active VNS
Sham VNS
Arm rehabilitation
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Spinal Cord Injury focused on measuring vagus nerve stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: a diagnosis of traumatic incomplete (AIS B-D) cervical spinal cord injury (C8 and above) at least 12 months post-traumatic SCI demonstrate some residual movement in the upper limb (e.g., able to perform pinch movement with thumb and index finger) meet all clinical criteria for the surgical VNS implantation as determined by the PI, neurosurgeon, and anesthesiologist. Exclusion Criteria: non-traumatic SCI, injury presence of ongoing dysphasia or aspiration difficulties evidence of vagus pre-existing vocal cord paralysis as determined with laryngoscopy procedure participants with prior left-sided anterior cervical surgery who exhibit too much of scar tissue at the surgery site which will be determined by neurosurgeon concomitant clinically significant brain injury history of prior injury to a vagus nerve receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry other comorbidities or complications that will hinder or contraindicate surgical procedure medical or mental instability pregnancy or plans to become pregnant during the study period.

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment group

Control Group

Arm Description

Participants in the treatment group will receive 18 goal-directed upper extremity rehabilitation therapy sessions with paired VNS over six weeks. Followed by 90 days home exercise program.

Participants in the control group will receive 18 goal-directed upper extremity rehabilitation therapy sessions with sham VNS over six weeks. Followed by 90 days home exercise program.

Outcomes

Primary Outcome Measures

Safety as assessed by number of subjects with post surgical complications
post-surgical complications include but are not limited to dysphagia, hematoma, hoarseness of voice, vocal cord paralysis, edema, pain, and post-surgical infection
Safety as assessed by number of subjects with change in systolic blood pressure
Safety as assessed by number of subjects with change in diastolic blood pressure
Safety as assessed by number of subjects with change in heart rate
Safety as assessed by number of subjects with change in respiratory rate
Safety as assessed by number of subjects with change in autonomic dysreflexia
Safety as assessed by number of subjects with worsening spasticity
Safety as assessed by number of subjects with change in pain at stimulation site
Feasibility as assessed by the number of participants that completed all the sessions
Feasibility as assessed by the number of participants that dropped out of the study

Secondary Outcome Measures

Change in hand function as assessed by the Toronto Rehab Institute Hand Function Test (TRI-HFT)
This is a 14 item questionnaire and each is scored from 1(no movement elicited) to 8(normal grasp) a higher number indicating better hand function
Change in capability of using arms and hands as assessed by the Capabilities of Upper Extremity Questionnaire (CUE-Q)
This is a 17 item questionnaire and each is scored from 1(totally limited) to 7(not at all limited), a higher number indicating better outcome
Change in self care independence as assessed by the Spinal Cord Injury Independence Measure-III (SCIM-III) self-care subscore
This is a 4 item questionnaire and each is scored from 0(need total assistance) to 3(completely independent), higher score indicating more independence.
Quality of Life as assessed by the Spinal Cord Injury- Quality of Life (SCI-QoL) questionnaire
This questionnaire has 3 parts: basic mobility: this is a 11 item questionnaire and each is scored from 1(unable to do) to 5(can do without difficulty)higher score indicating more mobility Fine Motor: This is a 9 item questionnaire and each is scored from 1(unable to do) to 5(can do without difficulty)higher score indicating better outcome self care: This is a 11 item questionnaire and each is scored from 1(unable to do) to 5(can do without difficulty)higher score indicating better outcome
Change in Pain as assessed by the International SCI pain basic data subset (version 2).
This is an 6 item questionnaire and each is scored from 0 (no pain) -10 (pain as bad as you can imagine), a higher score indicating more pain.
Change in Depression as assessed by the Patient Health Questionnaire (PHQ-8)
This is an eight item questionnaire and each is scored from 0(not at all) to 3(nearly every day) a higher score indicating worse outcome
Change in degree of upper limb impairment as assessed by the Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) survey.
The 3 measured domains are as follows: Strength: Motor grading of 10 arm and hand muscles for right and left arm will be performed. Each muscle is graded from 0 to 5 for a maximum score of 50, a higher number indicating more strength. Dorsal and palmar sensation: Each test location is scored from 0 to 4. Three locations for the dorsal side of each hand and 3 for palmer location of each hand are summed to render a subtest total score between 0 and 12 a higher score indicating more sensation. Prehension: Qualitative prehension: The participant performs 3 tasks using each hand and is scored from 0-12 a higher number indicating a better outcome Quantitative prehension: he participant performs 6 tasks using each hand and is scored from 0-30 a higher number indicating a better outcome

Full Information

First Posted
October 17, 2022
Last Updated
May 16, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
MicroTransponder Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05601661
Brief Title
Safety and Feasibility of Paired Vagus Nerve Stimulation With Rehabilitation for Improving Upper Extremity Function in People With Cervical Spinal Cord Injury
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
MicroTransponder Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spinal Cord Injury
Keywords
vagus nerve stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Participants in the treatment group will receive 18 goal-directed upper extremity rehabilitation therapy sessions with paired VNS over six weeks. Followed by 90 days home exercise program.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Participants in the control group will receive 18 goal-directed upper extremity rehabilitation therapy sessions with sham VNS over six weeks. Followed by 90 days home exercise program.
Intervention Type
Device
Intervention Name(s)
Active VNS
Intervention Description
An implantable system consisting of an implantable neurostimulator (model 1001 Implantable Pulse Generator (IPG)) and an implantable lead and electrode (Model 30000 VNS lead) will be used. An external system consisting of an external controller (Model 2000 Wireless Transmitter) and an external software system (computer and Model 4001 Microtransponder SAPS® software) will provide clinical control of settings for the implantable pulse generator (IPG) . All VNS devices (Vivistim System® ) will be provided as a donation by Microtransponder Inc. The device is programmed to stimulate for 0.5s on each button push. After surgical recovery, participants will receive five stimulations in reducing strength (starting at 0.8mA and then reducing to 0.1mA each step) at the beginning of each therapy session, followed by stimulation (0.8 mA)
Intervention Type
Device
Intervention Name(s)
Sham VNS
Intervention Description
An implantable system consisting of an implantable neurostimulator (model 1001 Implantable Pulse Generator (IPG)) and an implantable lead and electrode (Model 30000 VNS lead) will be used. An external system consisting of an external controller (Model 2000 Wireless Transmitter) and an external software system (computer and Model 4001 Microtransponder SAPS® software) will provide clinical control of settings for the implantable pulse generator (IPG) . All VNS devices (Vivistim System® ) will be provided as a donation by Microtransponder Inc. The device is programmed to stimulate for 0.5s on each button push. After surgical recovery, participants will receive five stimulations in reducing strength (starting at 0.8mA and then reducing to 0.1mA each step) at the beginning of each therapy session, followed by stimulation (0 mA)
Intervention Type
Other
Intervention Name(s)
Arm rehabilitation
Intervention Description
. The rehabilitation therapy involves arm and hand exercises with objects. The therapist will select these exercises based on movement abilities. Tasks will be selected from six functional task categories: reach and grasp, gross movement, object flipping, simulated eating tasks, inserting objects, and opening containers. Approximately 30-50 repetitions will be performed in each category. On average, 300-500 repetitions will be performed during each session within 1.5-2hours.
Primary Outcome Measure Information:
Title
Safety as assessed by number of subjects with post surgical complications
Description
post-surgical complications include but are not limited to dysphagia, hematoma, hoarseness of voice, vocal cord paralysis, edema, pain, and post-surgical infection
Time Frame
90-day follow-up
Title
Safety as assessed by number of subjects with change in systolic blood pressure
Time Frame
pretreatment, post treatment (about 6 weeks after pre treatment )
Title
Safety as assessed by number of subjects with change in diastolic blood pressure
Time Frame
pretreatment, post treatment (about 6 weeks after pre treatment )
Title
Safety as assessed by number of subjects with change in heart rate
Time Frame
pretreatment, post treatment (about 6 weeks after pre treatment )
Title
Safety as assessed by number of subjects with change in respiratory rate
Time Frame
pretreatment, post treatment (about 6 weeks after pre treatment )
Title
Safety as assessed by number of subjects with change in autonomic dysreflexia
Time Frame
pretreatment, post treatment (about 6 weeks after pre treatment )
Title
Safety as assessed by number of subjects with worsening spasticity
Time Frame
pretreatment, post treatment (about 6 weeks after pre treatment )
Title
Safety as assessed by number of subjects with change in pain at stimulation site
Time Frame
pretreatment, post treatment (about 6 weeks after pre treatment )
Title
Feasibility as assessed by the number of participants that completed all the sessions
Time Frame
end of study(about 132 days after enrollment)
Title
Feasibility as assessed by the number of participants that dropped out of the study
Time Frame
end of study(about 132 days after enrollment)
Secondary Outcome Measure Information:
Title
Change in hand function as assessed by the Toronto Rehab Institute Hand Function Test (TRI-HFT)
Description
This is a 14 item questionnaire and each is scored from 1(no movement elicited) to 8(normal grasp) a higher number indicating better hand function
Time Frame
baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.
Title
Change in capability of using arms and hands as assessed by the Capabilities of Upper Extremity Questionnaire (CUE-Q)
Description
This is a 17 item questionnaire and each is scored from 1(totally limited) to 7(not at all limited), a higher number indicating better outcome
Time Frame
baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.
Title
Change in self care independence as assessed by the Spinal Cord Injury Independence Measure-III (SCIM-III) self-care subscore
Description
This is a 4 item questionnaire and each is scored from 0(need total assistance) to 3(completely independent), higher score indicating more independence.
Time Frame
baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.
Title
Quality of Life as assessed by the Spinal Cord Injury- Quality of Life (SCI-QoL) questionnaire
Description
This questionnaire has 3 parts: basic mobility: this is a 11 item questionnaire and each is scored from 1(unable to do) to 5(can do without difficulty)higher score indicating more mobility Fine Motor: This is a 9 item questionnaire and each is scored from 1(unable to do) to 5(can do without difficulty)higher score indicating better outcome self care: This is a 11 item questionnaire and each is scored from 1(unable to do) to 5(can do without difficulty)higher score indicating better outcome
Time Frame
baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.
Title
Change in Pain as assessed by the International SCI pain basic data subset (version 2).
Description
This is an 6 item questionnaire and each is scored from 0 (no pain) -10 (pain as bad as you can imagine), a higher score indicating more pain.
Time Frame
baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.
Title
Change in Depression as assessed by the Patient Health Questionnaire (PHQ-8)
Description
This is an eight item questionnaire and each is scored from 0(not at all) to 3(nearly every day) a higher score indicating worse outcome
Time Frame
baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.
Title
Change in degree of upper limb impairment as assessed by the Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) survey.
Description
The 3 measured domains are as follows: Strength: Motor grading of 10 arm and hand muscles for right and left arm will be performed. Each muscle is graded from 0 to 5 for a maximum score of 50, a higher number indicating more strength. Dorsal and palmar sensation: Each test location is scored from 0 to 4. Three locations for the dorsal side of each hand and 3 for palmer location of each hand are summed to render a subtest total score between 0 and 12 a higher score indicating more sensation. Prehension: Qualitative prehension: The participant performs 3 tasks using each hand and is scored from 0-12 a higher number indicating a better outcome Quantitative prehension: he participant performs 6 tasks using each hand and is scored from 0-30 a higher number indicating a better outcome
Time Frame
baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a diagnosis of traumatic incomplete (AIS B-D) cervical spinal cord injury (C8 and above) at least 12 months post-traumatic SCI demonstrate some residual movement in the upper limb (e.g., able to perform pinch movement with thumb and index finger) meet all clinical criteria for the surgical VNS implantation as determined by the PI, neurosurgeon, and anesthesiologist. Exclusion Criteria: non-traumatic SCI, injury presence of ongoing dysphasia or aspiration difficulties evidence of vagus pre-existing vocal cord paralysis as determined with laryngoscopy procedure participants with prior left-sided anterior cervical surgery who exhibit too much of scar tissue at the surgery site which will be determined by neurosurgeon concomitant clinically significant brain injury history of prior injury to a vagus nerve receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry other comorbidities or complications that will hinder or contraindicate surgical procedure medical or mental instability pregnancy or plans to become pregnant during the study period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Radha Korupolu, MD
Phone
713-797-5233
Email
Radha.Korupolu@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alyssa Miller
Phone
713-797-7132
Email
Alyssa.Miller@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radha Korupolu
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radha Korupolu
Phone
713-797-5233
Email
Radha.Korupolu@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Alyssa Miller
Phone
713-797-7132.
Email
Alyssa.Miller@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Feasibility of Paired Vagus Nerve Stimulation With Rehabilitation for Improving Upper Extremity Function in People With Cervical Spinal Cord Injury

We'll reach out to this number within 24 hrs