Natural Sensory Feedback for Phantom Limb Modulation and Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Phantom limb pain
研究概览
简要总结
Background:
Phantom limb pain (PLP) develops in 50-80% of subjects who have a limb amputated. It is not well known what causes PLP to develop and the current treatments have been shown to be largely ineffective. Resent research, however, have indicated that cortical reorganizing occurring after amputation of the cortex areas related to the missing limb may be related to the development of PLP. Furthermore, the research indicated that by providing meaningful sensory input coming from the phantom limb the PLP may be alleviated and the cortical organization normalized.
Aim:
The CIP described in the current application, is part of a the EU-project "EPIONE", which aims to investigate if and how cortical normalization and PLP alleviation can be induced by providing phantom limb sensations (sensations which seems to originate from the missing limb) in hand amputated subjects.
Method:
In the current study, which will take place at Aalborg University Hospital (AUH), 2-4 hand amputated subjects experiencing severe PLP will implanted with interneural nerve electrodes in the arm stump for up to one year.
Therapy will be evaluated in two stages, first during a standardized four week phase where the subject receives daily therapy. If the therapy is shown to be effective, therapy may be reinitiated during a second longer therapy phase.
During the therapy sessions, selective nerve stimulation will be performed. The amputee will experience this as sensations (movement, touch, temperature, vibration etc.) originating from the phantom limb. While implanted, we will investigate how well we can induce these sensations and we will provide a stimulation therapy, which consist of stimulation activities which requires the subject to focus on the evoked sensations. Prior to, during a 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 subject.
Expected outcome:
The stimulation therapy is expected to alleviate PLP and induce cortical normalization. The experience we gain might be used for deriving clinical guidelines on how to treat PLP.
详细描述
The study will be carried out in two parts. The first part will function as a pilot part where the investigators will seek to get experience with, e.g., stimulation procedures: Which therapies activities and stimulation parameters do the participants feel are the most intuitive (i.e., most effective reintroducing the phantom hand into the body image of the amputee) and thus might be expected to be most effective in normalizing the cortical organization and alleviating PLP.
After part 1 the data will be analyzed together with the international partners (no participants identifiable data will be shared) and the shared experiences will be used to adjust the activities of part two.
The experiment is conducted in the following phases:
- Startup
- Pre-screening
- Baseline and entry
- Implantation (defined as week 0)
- Therapy
- Outcome
- Follow-up
- Repetition. Redo phase 3 to 7 with longer therapy phase durations only
Procedures during phases 1 to 7 (weeks -5 to 12) are standardized across international EPIONE partners (which carry out different interventions, but similar assessments), to enable comparison between treatment modalities. At AUH, if therapy is shown to be effective during phase 1-7, the investigators will repeat the initial phases 3 to 7, but with a longer therapy phase, to investigate the effect of long term stimulation therapy. TIME-4H electrodes will not be left implanted for a longer duration than one year.
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
- •Adult man or woman >18 yrs and < 70 yrs.
- •Unilateral transradial amputation.
- •Other treatments for PLP tried with poor results
- •Patient accepts the study protocol as explained by the physician.
- •The subject must experience intractable PLP higher than 6 on a Visual Analog Scale (VAS) from 0-
- •The frequency of PLP attacks must present itself more than once a week.
- •Amputation should be in the chronic, stable phase, such that the stump has healed and the person apart from experiencing phantom pain is healthy and able to carry out the experiment.
排除标准
- •Cognitive impairment
- •Current or prior psychological impairments: major personality disturbance (i.e., borderline, antisocial), major depression, bipolar I.
- •Pregnant (if fertile woman: assessed via a pregnancy test) or not using contraception accepted by the authorities during the study
- •Breastfeeding women cannot participate in the study
- •History of or active substance abuse disorder.
- •Acquired brain injury with residual impairment
- •Intellectual Disability (IQ < 70)
- •Current or prior neurological or musculoskeletal disease
- •Current or prior dermatological conditions
- •Persons with other diseases that may affect the function of the nervous system, e.g., diabetes, HIV or renal failure.
- •Subjects who will not be able to have an fMRI examination conducted because of metal implants such as: pacemakers, artificial joints, bone screws.
- •Subjects who suffer from claustrophobia and who are unable of having an fMRI examination conducted (the examination requires the subject to lie inside a narrow space in the MRI machine).
- •Subjects cannot participate in other clinical studies and/or tests of medical devices
结局指标
主要结局
Phantom limb pain
时间窗: Change in pain perception over 3 -15 months. (Time frame is dependent on effect of treatment)
The pain intensity will be assessed using a visual analog scale (VAS) analog scale (VAS), the neuropatic pain sympton inventory (NPSI), the brief pain inventory interference scale (BPSI)
Cortical reorganization
时间窗: Change in pain perception over 3 -15 months. (Time frame is dependent on effect of treatment)
The cortical response to peripheral stimulation will be tracked using MRI MRI and EEG.
次要结局
- Cortical reorganization(Change in pain perception over 3 -15 months. (Time frame is dependent on effect of treatment))
- Phantom limb pain(Change in pain perception over 3 -15 months. (Time frame is dependent on effect of treatment))