Neuropathic Pain and Operant Conditioning of Cutaneous Reflexes After SCI

Официальное название

Targeted Spinal Cord Plasticity for Alleviating SCI-related Neuropathic Pain

Обзор

The purpose of the second part of the study is to examine the effect of reflex training in the leg to decrease neuropathic pain. For this, the researchers are recruiting 15 individuals with neuropathic pain due to spinal cord injury to participate in the reflex training procedure. The study involves approximately 50 visits with a total study duration of about 6.5 months (3 months for baseline and training phases followed by 1 month and 3 month follow-up visits).

Подробное описание

As part of the larger study of the relationship between reflexes in the leg and the presence of neuropathic pain, the researchers are also recruiting 30 individuals with spinal cord injury (SCI) total, 15 individuals with neuropathic pain due to SCI and 15 individuals without neuropathic pain. For this portion of the study, there are 2 visits. The first visit will examine cutaneous reflexes in the leg. During the second visit, the study team will assess sensation in the leg and administer questionnaires about pain, functioning, and quality of life. This portion of the study does not involve an intervention.

The study will then recruit 15 individuals who will participate in reflex training, as described in the brief summary.

Вмешательства

• Поведенческое Operant Conditioning of Cutaneous Reflexes
  This is a training intervention in which people with a spinal cord injury are trained to change (increase or decrease) the activity of a certain spinal reflex. By changing this reflex, it is hypothesized that individuals can reduce pain due to spinal cord injury.

Первичные конечные точки

• Change in minimum stimulation intensity required to barely detect the sensation (perceived threshold, perT) [Срок оценки: change from baseline to immediately after completing the training protocol, at 1 month follow up and at 3 months follow up]
• Change in minimum intensity at which the sensation covers the maximum area of skin (radiating threshold, RT) [Срок оценки: change from baseline to immediately after completing the training protocol, at 1 month follow up and at 3 months follow up]
• Change in minimum intensity at which the stimulus become painful (pain threshold, PainT) [Срок оценки: change from baseline to immediately after completing the training protocol, at 1 month follow up and at 3 months follow up]
• Change in pain as measured by the McGill Pain Questionnaire (MPQ) [Срок оценки: Completed at baseline, start of conditioning visits 13, 19, and 25, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up]
• Change in neuropathic pain as measured by the Neuropathic Pain Symptom Inventory (NPSI) [Срок оценки: Completed at baseline, start of conditioning visits 13, 19, and 25, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up]

Вторичные конечные точки (4)

• Change in ability to perceive various types of sensations as indicated by Quantitative Sensory Testing (QST) [Срок оценки: Completed at baseline, start of conditioning visits 13, 19, and 25, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up]
• Change in basic functional independence as measured by the Spinal Cord Independence Measure (SCIM III) [Срок оценки: Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up]
• Change in functional independence as measured by the Functional Independence Measure (FIM) [Срок оценки: Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up]
• Change in quality of life as measured by Spinal Cord Injury Quality of Life and Participation Questionnaire (SCI-QOL) [Срок оценки: Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up]

Критерии участия

Критерии включения

• neurologically stable (>1 year post SCI)
• medical clearance to participate
• ability to stand with or without an assistive device for at least 3 minutes at a time
• expectation that current medication will be maintained without change for at least 3 months (stable use of anti-spasticity medication is accepted)
• For participants with neuropathic pain, the area of neuropathic pain must include lower leg.

Критерии исключения

• motoneuron injury
• known cardiac condition
• medically unstable condition (incl. pregnancy)
• cognitive impairment
• uncontrolled peripheral neuropathy
• frequent use of electrical spinal stimulation (either transcutaneous or epidural) for pain treatment
• daily use of electrical stimulation to the leg
• complete lack of cutaneous sensation around foot.

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

Лечение

Центры проведения

США · 1 центр

• Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT05492188 · 118771 · CDMRP-SC210118

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗