Natural Sensory Feedback for Phantom Limb Modulation and Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Cortical reorganization (fMRI)
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 invasive sensory feedback (i.e. electrical stimulation through intraneural implantation of electrodes) and the effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.
详细描述
In the current study, which will take place at the Lausanne University Hospital (CHUV, Centre Hospitalier Universitaire Vaudois), 1-2 hand amputated patients experiencing severe PLP will be enrolled and implanted with intraneural nerve electrodes in the arm stump for up to maximal 6 months.
Nerve electrodes will be implanted in two nerves of the arm stump. During daily stimulation sessions the electrodes will be connected to an external stimulator via transcutaneous leads. During the sessions, selective nerve stimulation will be performed. The amputee patient will experience this as sensations (movement, touch, temperature, vibration etc.) originating from the phantom limb. While implanted, the investigators will investigate how well they can induce these sensations and they will provide a stimulation therapy, which consist of stimulation activities and therefore requires the patient to focus on the evoked sensations. Prior to, during and following therapy a series of assessments (standardized across all EPIONE partners to enable comparison) will be conducted to relate therapy with PLP, cortical organization, the mental state etc. of the patient.
Timing of clinical assessments is conducting in the following phases:
- First visit
- Pre-screening visit
- Baseline and Entry
- Implantation
- Intervention period: intensive therapy, preliminary outcome, semi-intensive therapy, monitoring
- Outcome
- Follow-up
- Explantation
Procedures are standardized across international EPIONE partners (which carry out different interventions, but similar assessments), to enable comparison between treatment modalities.
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
- •Unilateral transradial amputation.
- •Amputation should be in the chronic, stable phase, such that the stump has healed and the person apart from eventual phantom pain (PLP) is healthy and able to carry out experiments.
- •Other treatments for PLP tried with poor results.
- •Patient accepts the study protocol as explained by the physician.
- •The subject experienced intractable PLP of more than 6 on NRS or VAS (0-10 scale). The frequency of PLP episodes presents more than once a week.
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
结局指标
主要结局
Cortical reorganization (fMRI)
时间窗: Change in cortical reorganization before and at the end of treatment (from baseline to maximum 6 months)
The cortical response to peripheral stimulation will be tracked using fMRI
Phantom limb pain (questionnaires)
时间窗: Change in phantom limb pain perception during the all study (from baseline to maximum 6 months)
The pain intensity will be assessed using visual analog scale (VAS)
次要结局
- Cortical reorganization (EEG)(Change in cortical reorganization before and at the end of treatment (from baseline to maximum 6 months))
- Phantom limb pain (questionnaires)(Change in neuropathic pain symptoms during the all study (from baseline to maximum 6 months))
研究者
Prof. Wassim Raffoul
Professor
University of Lausanne Hospitals