Operant Conditioning of Sensory Evoked Potentials to Reduce Phantom Limb Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Pain as Measured by the Short form-McGill Pain Questionnaire (SF-MPQ)
研究概览
简要总结
The study will investigate the application of a non-pharmacological operant conditioning approach to reduce phantom limb pain (PLP). PLP afflicts 60-90% people who have lost a limb. It can last for years and lead to drug dependence, job loss, and poor quality of life. Current non-pharmacological interventions are encouraging but limited, and their efficacy remains unclear. Limb amputation is known to lead to abnormal sensorimotor reorganization in the brain. Multiple studies have shown that PLP severity is correlated with the extent of this reorganization. The current study will train participants via realtime feedback of brain responses to promote more normal sensorimotor response, with the goal to reduce phantom limb pain.
详细描述
The study will be recruiting people who have had a limb amputation (traumatic or atraumatic) and are experiencing chronic phantom limb pain (PLP). Participants will be asked to be seated during the study session. Non-painful peripheral stimulation will be applied to elicit an evoked response (from either muscle or brain). Electrodes will be placed on the muscles and or scalp to record these electrical brain responses during the study session. Visual feedback based on the response will be provided in pseudo realtime. The study will involve three 1-hour sessions per week for 8-9 weeks, followed by 2 follow-up sessions at 3 and 6 months after the last session. Assessments of pain intensity and quality, and neurophysiological sensorimotor response, will be performed before the first session, after the last session, and at follow-up sessions. Additional electroencephalography (EEG) based assessments will also be performed as exploratory measures, to assess inter- and intra- hemispheric functional connectivity and sensorimotor responses associated with amputation and operant conditioning training.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
- The pre and post clinical assessment will be performed by a blinded evaluator.
- The participant will not be told about group assignment till the end of the last follow-up session and assessment
- Investigators will keep blinded to the baseline clinical measures.
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
- •An upper (or lower limb) amputation more than 6 months ago, that has produced a moderate to severe hand/arm (or foot/leg) phantom limb pain,
- •Male or female age 18 years or older,
- •Medical clearance to participate,
- •Reasonable expectation that ongoing medications, if any, will be maintained without change for at least 4 months from the start of the study,
- •Able to provide informed consent and to understand the study instructions,
- •Able to participate in the specific study procedures.
排除标准
- •Presence of other medically unstable and/or infectious condition (e.g., uncontrolled diabetes with recent weight loss, diabetic coma, frequent insulin reactions),
- •A cardiac condition (e.g., history of myocardial infarction or congestive heart failure),
- •Cognitive and/or attention difficulties affecting participant's ability to follow study directions,
- •Known skin disorders or damaged skin at the anticipated at the scalp for EEG recording (e.g., unhealed wounds, broken skin).
- •Metal implants above the chest
研究组 & 干预措施
Intervention Group
Intervention group receives peripheral stimulation with realtime operant conditioning feedback training.
干预措施: Operant Conditioning with Peripheral Stimulation (Behavioral)
Control Group
Control group receives peripheral stimulation but without operant conditioning feedback.
干预措施: Control Group with Peripheral Stimulation Only (Behavioral)
结局指标
主要结局
Change in Pain as Measured by the Short form-McGill Pain Questionnaire (SF-MPQ)
时间窗: Baseline, end of training (session 20) i.e. approximately 10 weeks from baseline, follow-up at 3-months after training ends, follow-up at 6-months after training ends
The Sf-MPQ assesses the pain quality in the sensory (11 items) and affective (4 items) dimensions. Each item is rated on an intensity scale of 0 (none) to 3 (severe). Total score is obtained by summing the scores for all items and the range is 0 (no pain) to 45 (severe pain).
Change in Evoked Potential (EP) Amplitude and threshhold
时间窗: Baseline, end of training (session 20) i.e. approximately 10 weeks from baseline, follow-up at 3-months after training ends, follow-up at 6-months after training ends
The evoked response to tactile stimuli will be captured in one of two ways 1) EMG and Reflex evoke responses from cutaneous nerve on the residual Limb and 2) With 64 channel non-invasive scalp electroencephalography (EEG) electrodes placed on the scalp. SSEP will be assessed at the sensorimotor cortex contralateral to the amputated limb. An increase in amplitude will indicate improvement in the sensorimotor response and tolerance.
Change in Somatosensory Evoked Potential (SSEP) Latency as Measured by a Tactile Event Related Potential Test
时间窗: Baseline, end of training (session 20) i.e. approximately 10 weeks from baseline, follow-up at 3-months after training ends, follow-up at 6-months after training ends
The evoked response to tactile stimuli will be captured with 64 channel non-invasive scalp electroencephalography (EEG) electrodes placed on the scalp. SSEP will be assessed at the sensorimotor cortex contralateral to the amputated limb. A reduction in latency will indicate improvement in the sensorimotor cortical response.
次要结局
- Change in Impact of Pain on Quality of Life as Measured by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI)(Baseline, end of training (session 20) i.e. approximately 10 weeks from baseline, follow-up at 3-months after training ends, follow-up at 6-months after training ends)