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临床试验/NCT05563038
NCT05563038招募中不适用

Scrambler Therapy for Post-Stroke Pain

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年5月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Reduction in post stroke pain

研究概览

简要总结

The Investigators will enroll patients who have had a stroke and are experiencing post-stroke pain secondary to their infarct and disruption of the sensory system in a research study to compare the effectiveness of Scrambler Therapy to traditional pharmacologic therapies.

详细描述

Participants will work with the provider to decide which method of treatment they prefer and will then be followed regularly using standardized pain scores over the next year.

Those undergoing ST will undergo 5-10 sessions while those treated with medical therapy will undergo titration of medication as per typical standard of care. The investigators will compare both maximal pain relief achieved and duration achieved between groups.

prospectively enroll a consecutive series of patients presenting to clinic with post-stroke pain syndromes following either an ischemic infarct or intracranial hemorrhage. Patients will be included in the study if they are at least one month post-stroke (but can be chronic) and have pain in an area attributable to the location of their lesion (ie contralateral to a lesion involving the thalamus or sensory cortex). At their clinic visit, potential treatments: Scrambler Therapy or pharmacological treatment, will be discussed with each patient. Patients will not be excluded if they are currently taking or have taken pain medications in the past, though these variables will be factored into the analysis. Through shared decision making, the investigator along with the patients input will decide on ST versus medical management. Participants will consent to being followed for pain control over the following year of therapy to enable comparison of ST to standard medical therapy.

All patients will begin by rating their current pain on the Numerical Rating Scale (NRS) from 0-10.

Patients undergoing treatment by Scrambler Therapy will begin by describing the areas and levels of pain along the Numerical Rating Scale (NRS) from 0-10. The dermatomes of the areas of pain will be examined by going up and down the dermatome as shown on a dermatome map, and the electrode of the Scrambler machine will be placed at the site where pain is initiated and approximately 10 centimeters above it. The Scrambler machine will then be started and turned on until patients feel a "tingling" sensation that is not painful. For approximately 45 minutes, the Scrambler machine will run while a team member watches over the patient, adjusting the levels only if the patient no longer feels the tingling sensation.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women over the age of 18 with ischemic or hemorrhagic stroke seen on imaging and a positive finding for pain in the area(s) affected by their stroke location will be included.
  • The patients must be at least one month post-stroke but can otherwise enroll at any point.

排除标准

  • Patients with TIA
  • Patients with no evidence of stroke on MRI
  • Patients with implantable devices such as pacemakers, defibrillators, spinal cord stimulators
  • Patients with history of myocardial infarction in the past 6 months
  • Patients with uncontrolled epilepsy
  • Patients with symptomatic brain metastases

研究组 & 干预措施

Scrambler Therapy

Active Comparator

Using Scrambler Therapy for Post Stroke Pain all participants will either undergo either 5 or 10 treatments using Scrambler Therapy. The number of treatments will be decided by a randomization process.

干预措施: Scrambler Therapy for Post Stroke Pain (Device)

结局指标

主要结局

Reduction in post stroke pain

时间窗: 6 months

At least a 50% reduction in post stroke pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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