Harnessing Neuroplasticity to Enhance Functional Recovery in Allogeneic Hand Transplant and Heterotopic Hand Replant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- Change from Baseline Dellon Modified Moberg Pick-Up Test performance at two weeks.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Change from Baseline Dellon Modified Moberg Pick-Up Test performance at two weeks.
时间窗: Baseline, immediately after end of intervention (+/- 3 days).
This functional test measures quality of sensibility of the hand. This outcome measure will investigate any change in participant performance between pre- and post-intervention sessions of the Dellon Modified Moberg Pick-Up Test.
次要结局
- Change from Baseline Action Research Arm Test (ARAT) performance at two weeks.(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.(Baseline, post intervention at week 1, post intervention at 1 month, post intervention at 3 months, post intervention at 6 months.)
研究者
Scott H Frey, PhD
Miller Family Professor of Cognitive Neuroscience
University of Missouri-Columbia