Harnessing Neuroplasticity to Enhance Functional Recovery During Chronic Recovery From Upper Extremity Nerve Repair

Официальное название

Harnessing Neuroplasticity to Enhance Functional Recovery in Allogeneic Hand Transplant and Heterotopic Hand Replant Recipients

Обзор

This study adopts a strategy that has arisen from basic neuroscience research on facilitating adaptive brain plasticity and applies this to rehabilitation to improve functional recovery in peripheral nervous system injuries (including hand transplantation, hand replantation, and surgically repaired upper extremity nerve injuries). The technique involves combining behavioral training with transcranial direct current stimulation (tDCS)-a non-invasive form of brain stimulation capable of facilitating adaptive changes in brain organization.

Подробное описание

This study will implement and evaluate an innovative program of post hand transplant rehabilitation; one that harnesses recent discoveries in neuroscience to facilitate long-term, experience-dependent adaptations within the brain's sensory and motor systems. The current approach to rehabilitation of function in allogeneic hand transplant recipients is largely the same as standard-of-care following hand replantation (re-attachment) and peripheral nerve repairs. This involves an eclectic combination of traditional therapies. In seeking to improve on this approach, there is potentially much to be gained by considering evidence that limb amputation not only impacts the peripheral nervous system but also the brain, and tailoring interventions accordingly.

Вмешательства

• Устройство Transcranial Direct Current Stimulation
  Transcranial direct current stimulation (tDCS) is a portable neurostimulation method that modulates cortical excitability. The technique involves placing two saline-soaked electrodes (anode and cathode) on the scalp and passing a small direct current (1.5 milliamps; mA) between them. Cortex underlying the anode is more easily excited due to lowered thresholds for depolarization of glutamatergic neurons, while thresholds are increased in neurons beneath the cathode, making them less excitable. Sh
• Поведенческое Modified Constraint Induced Movement Therapy
  In CIMT, patients are required to wear a mitt that restricts use of the unaffected limb while they practice structured tasks and also engage in activities of daily living.

Первичные конечные точки

• Change from Baseline Dellon Modified Moberg Pick-Up Test performance at two weeks. [Срок оценки: Baseline, immediately after end of intervention (+/- 3 days).]

Вторичные конечные точки (2)

• Change from Baseline Action Research Arm Test (ARAT) performance at two weeks. [Срок оценки: Baseline, immediately after end of intervention (+/- 3 days).]
• Change from baseline upper limb movement as measured by actigraphy-derived variables during everyday life at periodic intervals after intervention. [Срок оценки: Baseline, post intervention at week 1, post intervention at 1 month, post intervention at 3 months, post intervention at 6 months.]

Критерии участия

Критерии включения

• Individuals whom have received a unilateral allogeneic transplantation proximal to the wrist and are at the chronic stage of recovery (approx. 12 - 18 months following surgery, when Tinel's sign reaches the distal fingertips).
• Individuals whom have undergone a complete amputation the hand between the wrist and elbow followed by successful re-attachment and are at the chronic stage of recovery (approx. 12 - 18 months following surgery, when Tinel's sign reaches the distal fingertips).
• Individuals whom have undergone repairs of the median, ulnar, or other related or nearby nerve(s) following complex volar forearm lacerations or other injuries between the distal wrist crease and the flexor musculotendinous junctions. Individuals must be at the chronic stage of recovery (approx. 12 - 18 months following surgery, when Tinel's sign reaches the distal fingertips).

Критерии исключения

• Individuals with significant/severe brain trauma
• Serious psychiatric conditions
• Chronic or severe neurological conditions.
• Current pregnancy
• History of seizures or unexplained loss of consciousness
• Metallic implants above the chest
• Certain implanted medical devices.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Christine Kleinert Institute for Hand & Microsurgery — Louisville
• University of Missouri — Columbia
• Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT03610763 · 2008784 · CDMRP-MR141043

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗