Safety and Feasibility of Paired Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) With Upper Limb Rehabilitation in Incomplete Spinal Cord Injury

Official title

Safety and Feasibility of Paired taVNS With Upper Limb Rehabilitation in Incomplete Spinal Cord Injury

Overview

The purpose of this study is to evaluate the safety and feasibility of transcutaneous auricular Vagus Nerve Stimulation (taVNS) paired with upper-limb rehabilitation in adults with tetraplegia caused by cervical spinal cord injury.

Interventions

• Device Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
  Participants will receive 18 goal-directed upper extremity rehabilitation therapy sessions with paired taVNS over six weeks, followed by a 90-day home exercise program.

Primary outcome measures

• Safety as assessed by number of subjects with change in systolic blood pressure [Time frame: Immediately after completing in-clinic 18 sessions (6-8 weeks)]
• Safety as assessed by number of subjects with change in diastolic blood pressure [Time frame: Immediately after completing in-clinic 18 sessions (6-8 weeks)]
• Safety as assessed by number of subjects with change in heart rate [Time frame: Immediately after completing in-clinic 18 sessions (6-8 weeks)]
• Safety as assessed by number of subjects with change in respiratory rate [Time frame: Immediately after completing in-clinic 18 sessions (6-8 weeks)]
• Safety as assessed by number of subjects with change in autonomic dysreflexia [Time frame: Immediately after completing in-clinic 18 sessions (6-8 weeks)]
• Safety as assessed by number of subjects with worsening spasticity [Time frame: Immediately after completing in-clinic 18 sessions (6-8 weeks)]
• Safety as assessed by number of subjects with change in pain at stimulation site [Time frame: Immediately after completing in-clinic 18 sessions (6-8 weeks)]
• Safety as assessed by number of adverse events that occurred during the study period [Time frame: post therapy 30 days]
• Feasibility as assessed by the number of treatment sessions attended by each participant . The intervention is considered feasible if at least 80% adherence rate is achieved and no serious adverse events occurred. [Time frame: from baseline through completion of 18 sessions (about 6-8 weeks)]
• Feasibility as assessed by the participants' perceptions of the study procedures [Time frame: from baseline through completion of 18 sessions (about 6-8 weeks)]

Secondary outcome measures (7)

• Change in degree of upper limb impairment as assessed by the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assessment [Time frame: Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]]
• Change in hand function as assessed by the Toronto Rehab Institute Hand Function Test (TRI-HFT) [Time frame: Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]]
• Change in capability of using arms and hands as assessed by the Capabilities of Upper Extremity Questionnaire (CUE-Q) [Time frame: Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]]
• Change in self care independence as assessed by the Spinal Cord Injury Independence Measure-III (SCIM-III) self-care subscore [Time frame: Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]]
• Change in Quality of Life as assessed by the Spinal Cord Injury- Quality of Life (SCI-QoL) questionnaire [Time frame: Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]]
• Change in Pain as assessed by the International SCI pain basic data subset (version 2) [Time frame: Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]]
• Change in Depression as assessed by the Patient Health Questionnaire (PHQ-8) [Time frame: Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]]

Eligibility criteria

Inclusion criteria

• diagnosis of traumatic incomplete (AIS B-D) cervical spinal cord injury (C8 and above)
• at least 12 months post-traumatic SCI but less than 10 years post-SCI
• demonstrate some residual movement in the upper limb (e.g., able to perform pinch movement with thumb and index finger sufficient to grip small objects such as marble)

Exclusion criteria

• non-traumatic SCI
• recent ear trauma and skin lesions at the site of stimulation, such as sunburn, cuts, and open sores,
• facial or ear pain,
• allergic reaction to adhesives and electrodes,
• any current or past history of cardiovascular disorders,
• intracranial metal implants, pacemakers,
• concomitant clinically significant brain injury,
• receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry
• If there is a plan for alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
• medical or mental instability;
• pregnancy or plans to become pregnant during the study period

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

United States · 2 centers

• Neurorecovery Research Center, TIRR MHH — Houston
• The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06543277 · HSC-MS-24-0346

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗