Natural Sensory Feedback for Phantom Limb Modulation and Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Cortical reorganization
研究概览
简要总结
Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously difficult to treat. Amputation usually follows traumatic injuries or surgery following vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is required for the survival of the patient. The loss of a limb or other body parts is usually followed by the sensation that the lost body part is still present and can be felt. These phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure on the residual limb) and psychological factors (e.g. emotional stress). It is well known that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic, psychological and other, are ineffective.
Today it is believed that phantom limb pain may be related to changes in the cortex of the brain. There is evidence that these changes may be modulated - or even reversed - by providing sensory input to the stump or amputation zone. For example, cortical reorganization and alleviation of phantom limb pain has been observed in amputees following intense use of a hand prosthesis. However, there is no consistent knowledge on which type of peripheral sensory feedback may be effective in affecting the cortical plasticity or on how to best apply the sensory feedback.
The aim of the proposed research is to create natural, meaningful sensations through providing non-invasive sensory feedback (i.e. surface electrical stimulation) and the effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.
详细描述
Purpose of the experiment Up to 50-80 % of persons with amputations experience pain in the part of the body that is missing. This phenomenon is called phantom limb pain. It is not clear today why phantom limb pain occurs, and since the pain can be difficult to treat, it can affect the quality of life. Other scientific studies have shown, that the use of electrical stimulation applied through surface electrodes, can assist to decrease or alleviate the phantom limb pain. The aim of this study is to investigate if surface electrical stimulation for a period of 3 months can decrease or alleviate the phantom limb pain.
Methods Before the study begins, it will be necessary to test if the participant can tolerate the electrical stimulation and that the participant fulfill all criteria for participating in the study. During the study, different electrical stimulation sequences will be applied. The participant will be asked to fill out a series of questionnaires before, during and after the electrical stimulation, to describe how the electrical stimulation is experienced, and if the stimulation had an effect on the phantom limb pain and phantom sensations. The participant will also be asked about their general mood to investigate if this has an effect on the pain. The brain signals of the participants will be measured twice with either surface electrodes or with a scanning technique, while the participant is thinking about moving the amputated arm/hand, while moving the healthy arm, or while receiving electrical stimulation.
Plan for the experiment The experiment will take place over a period of 3 months and consists of a series of measurement and intervention sessions planned in 2 phases (intensive and semi-intensive therapy). All sessions will take place at the University Hospital of Lausanne (CHUV), Switzerland.
Visit 0. Interview and meeting with the subject (before the experiment begins, 1 session, 1-2 hours). Before the experiment begins, the participant is invited to a meeting and interview with project responsible to inform the participant about the experiment.
Visit 1. Preliminary investigations (before the experiment starts, 1 session, maximum 3 hours pr session). Before the experiment starts, but after the participant has signed the informed consent, the investigators will test if the participant can tolerate the electrical stimulation.The evoked sensory feedback sensations over the hand, will be characterized by non-invasive, transcutaneous electrical stimulation of the peripheral nerves in different locations on the upper limb, both when stimulating single channel per at time, or several channels simultaneously. This session will allow to identify the electrical stimulation optimal parameters (amplitude, frequency and pulse-width) to induce sensations on the hand and how to modulate these sensations, close to natural pattern. A protocol to be integrated in a close-loop (bidirectional control) system of artificial hand will be developed. If all criteria for participation are fulfilled, the participation of the subject will be decided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Amputation or peripheral nerve damage of an upper limb.
- •Injury should be in the chronic, stable phase, such that any traumatic injuries or surgical wounds have healed and the person apart from eventual phantom pain (PLP) is healthy and able to carry out experiment.
- •Other treatments for PLP tried with poor results.
- •Patient accepts the study protocol as explained by the physician.
- •The subject experienced intractable PLP (i.e. pain in the denervated or missing extremity) of more than 6 on numerical rating scale (NRS) or visual analog scale (VAS) (0-10 scale). The frequency of PLP episodes presents more than once a week.
- •Amputee subjects without PLP are eligible for part of the study that targets the sensory feedback induction within advanced bidirectional prosthesis control.
排除标准
- •Cognitive impairment
- •Current or prior psychological impairments: Major personality disturbance (i.e. borderline, antisocial), Major depression, Bipolar I.
- •Pregnancy
- •History of or active substance abuse disorder
- •Acquired brain injury with residual impairment
- •Intellectual Disability (IQ < 70)
- •Prior neurological or musculoskeletal disease
- •Current or prior dermatological conditions
- •Excessive sensitivity to electrical stimulation with surface electrodes. People afraid of electrical stimulation or pain.
- •People with other diseases which may affect the function of the nervous system. (Diabetes, HIV, Renal Failure)
- •Patients implanted with pacemakers
研究组 & 干预措施
Surface electrical stimulation
Operation of hand prosthesis with surface electrical sensory feedback
干预措施: Surface electrical stimulation (Device)
结局指标
主要结局
Cortical reorganization
时间窗: Change in cortical reorganization between baseline measurements and 3 months
The cortical response to peripheral stimulation will be tracked using MRI
Phantom limb pain
时间窗: Change in phantom limb pain perception between baseline measurements and 3 months
The pain intensity will be assessed using visual analog scale (VAS)
次要结局
- Phantom limb pain(Change in neuropathic pain symptoms between baseline measurements and 3 months)
- Cortical reorganization(Change in in cortical reorganization between baseline measurements and 3 months)
研究者
Prof. Wassim Raffoul
Professor
University of Lausanne Hospitals