Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement

Обзор

In the United Kingdom, there are more than 1000 new cases of spinal cord injury (SCI) each year, with around half of these injuries affecting the cervical spine. People who have reduced function and control affecting their upper limbs may have difficulty carrying out activities of daily living (ADLs), significantly affecting their independence. Recovering even partial upper limb function is a top priority among tetraplegics. Regaining voluntary function in the upper limb can have a huge impact on quality of life. Using TSCS in the upper limb for acute SCI can benefit patients early in their rehabilitation, and may reduce the number of patients with problematic spasticity at discharge. Transcutaneous spinal cord stimulation (TSCS) may provide a low-cost method of improving function and spasticity in this cohort. The aim of this feasibility study is to assess and compare the impact of adding TSCS to the standard rehabilitation of inpatients with acute SCI, compared to a sham (placebo) TSCS intervention added to standard rehabilitation, in an effort to enhance upper limb control and function.

Подробное описание

Recruitment:

Participants will be recruited from the Royal National Orthopaedic Hospital. A member of our research team will contact participants after they have received this information sheet to discuss participation in the study and answer any questions. People who would like to take part in the study will be asked to attend an initial session to see if they are able to tolerate non-invasive SCS.

Intervention:

Eligible participants will then be randomised either into the intervention group, where they will receive TSCS or sham TSCS in addition to their regular inpatient rehabilitation. We are using this trial design to assess whether adding TSCS to regular inpatient rehabilitation enhances recovery and voluntary function in this participant cohort, and to test that there is not a placebo effect.

For both the sham and intervention groups, we will carry out regular assessments. Some of these assessments will be part of standard care as an inpatient at the RNOH, and others will be additional. Please see the outcome measures for further information about these assessments.

Follow-up:

When participants have finished their inpatient rehabilitation at the RNOH, we will carry out a semi-structured interview, where we will ask about participants' experience on this study. Interviews may take place in person, over the phone, or over video call (e.g. Microsoft Teams or Zoom).

Participants will then be invited to two Follow-up Assessments at the RNOH, where all outcome measures will be repeated. Follow-up 1 will be done once the participant is 6-months post-injury, and Follow-up 2 will be done at 1-year post-injury. If the participant is already 6-months post-injury at discharge, then Follow-up 1 will occur at 1-month post-discharge.

Вмешательства

• Другое Transcutaneous spinal cord stimulation added to inpatient rehabilitation
  Non-invasive electrical stimulation delivered over the spine, targetting movement of the upper limbs
• Другое Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation
  Sham transcutaneous spinal cord stimulation (placebo) added to Standard inpatient rehabilitation given at the Royal National Orthopaedic Hospital NHS Trust

Первичные конечные точки

• Change in International Standards of Neurological Classification for SCI (ISNC-SCI). [Срок оценки: 30 minutes]

Вторичные конечные точки (8)

• Modified Ashworth Scale (MAS) [Срок оценки: 20 minutes]
• Range of Motion (ROM) [Срок оценки: 20 minutes]
• Electromyography (EMG) assessments [Срок оценки: 90 minutes]
• Individual goal planning [Срок оценки: 20 minutes]
• Spinal Cord Independence Measure (SCIM) [Срок оценки: 30 minutes]
• Tetraplegic upper limb activity questionnaire (TUAQ) [Срок оценки: 30 minutes]
• International SCI data sets quality of life basic data set (SCI-QoL) [Срок оценки: 15 minutes]
• Semi-structured interview [Срок оценки: 60 minutes]

Критерии участия

Критерии включения

• Over the age of 18
• Recent spinal cord injury (inpatient at the RNOH)
• Spinal cord injury level C1-C8
• AIS A-D
• Willing and able to provide informed consent

Критерии исключения

• Women who are pregnant, planning pregnancy or breastfeeding
• Those who have a cardiac pacemaker
• Active device at stimulating electrode site
• Any other musculoskeletal diagnosis affecting the upper limbs
• Spinal malignancy
• Spinal cord injury due to cancerous growth
• Auto-immune disorder
• Ongoing infection
• Uncontrolled autonomic dysreflexia
• Complex regional pain syndrome
• Neurological degenerative diseases
• Peripheral nerve damage affecting the upper limbs
• Taking part in a conflicting research study
• People who are unable to tolerate TSCS during their first session

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• Royal National Orthopaedic Hospital — London

Идентификаторы

NCT: NCT05991804 · 319893

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗