Evaluation of Neuroprosthesis with Sensory Feedback for Modulation of Phantom Limb Pain and Enhancing Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- VAS
研究概览
简要总结
This clinical trial is designed to assess the effectiveness of advanced neuromodulation techniques in reducing phantom limb pain by improving sensory feedback in bionic prostheses. The study will explore the use of Peripheral Nerve Stimulation to evaluate their impact on pain relief and sensory restoration. The trial aims the development of neuroprostheses that can provide sensory feedback through stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Amputation of the upper limb at the level of the forearm or upper arm, or amputation of the lower limb at the level of the lower leg or thigh.
- •Age between 18 and 65 years.
- •Duration since amputation is at least 6 months.
- •Presence of persistent chronic pain syndrome rated between 4 and 10 on the Visual Analog Scale (VAS).
- •Absence of pregnancy at the time of implantation, confirmed by a pregnancy test (for female participants only).
- •Signed consent to participate in the study.
排除标准
- •Presence of severe somatic pathology that hinders surgical treatment and participation in the study.
- •Presence of psychiatric disorders (including a history of), severe depression, suicidal tendencies, or a history of suicide attempts.
- •Presence of severe orthopedic deformity in the limb above the level of amputation.
- •History of cancer.
- •History of epilepsy.
- •Complicated traumatic brain injury (TBI) or a history of stroke.
- •Inability to undergo electrostimulation due to other somatic pathology.
- •Purulent-septic pathology.
- •Drug addiction (including a history of).
- •Congenital anomaly of upper limb development.
- •Anomalies in the development of the central and peripheral nervous systems.
结局指标
主要结局
VAS
时间窗: up to 4 months
The Visual Analog Scale (VAS) is a 10 cm line used to measure pain intensity. One end of the line represents \"no pain,\" while the other end signifies \"worst possible pain.\" The line can be either horizontal or vertical.
DN 4
时间窗: Up to 6 months
The DN4 (Douleur Neuropathique 4) questionnaire is a diagnostic tool designed to identify neuropathic pain, caused by nerve damage. It includes 10 items divided into two sections. The first part consists of seven questions that assess the patient's pain symptoms, such as burning, tingling, electric shocks, or numbness. The second part involves a clinical examination where the physician tests for reduced sensitivity to touch and pinprick, as well as pain response to light brushing. Each item is scored with 1 point for "Yes" and 0 for "No." A total score of 4 or higher indicates a high probability of neuropathic pain.
SF-36
时间窗: up to months
The questionnaire consists of 36 items grouped into eight scales: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health. Each scale ranges from 0 to 100, where 100 represents full health. Higher scores indicate better quality of life, with two summary measures: physical and mental well-being.
次要结局
- Sensory threshold change(At least three measurements. 1 - First week after implantation, 2 - Up to three months after implantation, 3 - Up to five months after implantation)
- Agency(Up to 6 months)
- Pain detect(Up to 6 months)
- Embodiment(Up to 6 months)
- Hospital Anxiety and Depression Scale (HADS)(Up to 6 months)
- Ownership(Up to 6 months)