NCT06214949招募中不适用
Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) as a Treatment for Chronic Neck Pain
Henry M. Jackson Foundation for the Advancement of Military Medicine2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Defense & Veterans Pain Rating Scale (DVPRS)
研究概览
简要总结
This study aims to assess the efficacy of Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) therapy to reduce chronic neck for military health system beneficiaries.
详细描述
The objective of our proposed research is to (a) assess the efficacy of PrTMS therapy in reducing pain for military health system beneficiaries with chronic neck pain receiving standard of care* at Walter Reed National Military Medical Center, and (b) to describe participants' perceptions of PrTMS treatment and its perceived effect on their pain.
The specific aims for this study are as follows:
Specific Aims
Aim 1a: To assess the efficacy of PrTMS therapy in reducing pain for military health system beneficiaries with chronic neck pain receiving standard of care at Walter Reed National Military Medical Center.
Aim 1b: To describe participants' perceptions of PrTMS treatment and its perceived effect on their pain.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Military health care beneficiary for enrollment.
- •Over the age of 18 years.
- •Presence of chronic neck pain for at least 3 months.
排除标准
- •History of seizure, bipolar disorder, or schizophrenia.
- •Unstable heart or pulmonary disease.
- •Brain tumor, active brain infection, history of cerebral vascular accident (CVA), or penetrating brain injury.
- •Use of medications that potentially lower seizure threshold without concomitant administration of anticonvulsant drugs that may protect against seizure occurrence.
- •Antiviral medications and antipsychotic medications
- •Recent withdrawal from sedatives
- •Substance abuse of phencyclidine, amphetamines, ketamine, and gammahydroxybutyrate
- •Not a suitable candidate for the study as determined by the PI.
- •Pregnancy, breastfeeding, or plans to become pregnant during the course of the study.
- •Presence of metallic hardware in close contact to the discharging coil (e.g. cochlear implants, internal pulse generator).
- •Presence of implanted brain electrodes (cortical or deep-brain electrodes).
- •Potential participants who score above a certain suicide relevant survey score on the Suicide Behaviors Questionnaire-Revised (SBQ-R), or are judged by expert clinicians to be a serious risk of harm to self, will be excluded.
- •Participants cannot have undergone a previous TMS treatment within the last 30 days before the start of study treatment.
- •Participants must have reliable and consistent access to the internet to complete surveys when not present in the clinic.
- •Participants must not have a clinical diagnosis of insomnia.
- •Participants can not be actively partaking in a substance abuse program.
结局指标
主要结局
Defense & Veterans Pain Rating Scale (DVPRS)
时间窗: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements taken everyday during Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up
The DVPRS was developed to standardize pain measurement across all health care settings and promote pain assessment and reassessment practices. DVPRS is a visual pain scale to assess individual's pain intensity on a scale of 0-10, with an additional 4 questions to assess pain's interference with the participant's activity, sleep, mood, and stress. The scale has excellent internal reliability and test-retest reliability.
次要结局
- Pain Anxiety Symptom Scale Short Form 20 (PASS)(Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up)
- Patient Health Questionnaire (PHQ-9)(Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up)
- Generalized Anxiety Disorder 7-item scale (GAD-7)(Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up)
- Insomnia Severity Index (ISI)(Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up)
- Demographics Survey(Taken at Baseline to create comparable groups of treatment and will be used as covariates in statistical analysis.)
- Patient Global Impression of Change (PGIC)(Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up)
- TMS Tolerability Worksheet (TTW)(Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up)
- Sleep Condition Indicator (SCI)(Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up)
- Quantitative Analgesic Questionnaire (QAQ)(Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up)
- PTSD Checklist for DSM-5 (PCL-5)(Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up)
- Suicide Behaviors Questionnaire-Revised (SBQ-R)(Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up)
- Patient Reported Outcomes Measurement Information System (PROMIS) Scales.(Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up)
- Pittsburgh Sleep Quality Index (PSQI)(Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements will be taken once at end of Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up)
研究者
研究点 (2)
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