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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Safety as assessed by number of subjects with change in systolic blood pressure [Срок оценки: Immediately after completing in-clinic 18 sessions (6-8 weeks)]
• Safety as assessed by number of subjects with change in diastolic blood pressure [Срок оценки: Immediately after completing in-clinic 18 sessions (6-8 weeks)]
• Safety as assessed by number of subjects with change in heart rate [Срок оценки: Immediately after completing in-clinic 18 sessions (6-8 weeks)]
• Safety as assessed by number of subjects with change in respiratory rate [Срок оценки: Immediately after completing in-clinic 18 sessions (6-8 weeks)]
• Safety as assessed by number of subjects with change in autonomic dysreflexia [Срок оценки: Immediately after completing in-clinic 18 sessions (6-8 weeks)]
• Safety as assessed by number of subjects with worsening spasticity [Срок оценки: Immediately after completing in-clinic 18 sessions (6-8 weeks)]
• Safety as assessed by number of subjects with change in pain at stimulation site [Срок оценки: Immediately after completing in-clinic 18 sessions (6-8 weeks)]
• Safety as assessed by number of adverse events that occurred during the study period [Срок оценки: 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. [Срок оценки: from baseline through completion of 18 sessions (about 6-8 weeks)]
• Feasibility as assessed by the participants' perceptions of the study procedures [Срок оценки: from baseline through completion of 18 sessions (about 6-8 weeks)]

Вторичные конечные точки (7)

• Change in degree of upper limb impairment as assessed by the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assessment [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline, immediately after completing in-clinic 18 sessions (6-8 weeks), post- therapy 30 days, and posttherapy 90 days]]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 2 центра

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

Идентификаторы

NCT: NCT06543277 · HSC-MS-24-0346

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗