DoD AtMS for Posttraumatic Peripheral Neuropathic Pain

Официальное название

AtMS for Alleviating Posttraumatic Peripheral Neuropathic Pain (PTP-NP)

Обзор

The goal of this clinical trial is to learn if adaptative transcutaneous magnetic stimulation (AtMS) works to reduce pain caused by post-traumatic peripheral neuropathic pain (PTP-NP) within Veterans and/or active duty military personnel. It will also learn about the safety of AtMS. The main questions it aims to answer are: 1. What are the effects of adaptative tMS (AtMS) in alleviating patients' PTP-NP compared to fixed tMS (FtMS) and Sham-tMS? 2. What are the effects of AtMS in improving functions in patients suffering from PTP-NP compared to FtMS and Sham-tMS? 3. What are the effects of AtMS in improving mood in patients suffering from PTP NP compared FtMS and Sham-tMS? Researchers will compare AtMS, FtMS and Sham-tMS to see if AtMS is the best form of tMS in treating PTP-NP. Participants will undergo the following: 1. Receive a total of 8 AtMS, FtMS, or Sham-tMS treatments over 16 weeks. 2. Visit the clinic a total of 12 times for assessments, check ups, and treatments. 3. Keep a daily diary of their PTP-NP intensity, sleep interference, and pain medications used.

Подробное описание

This study will be enrolling a total of 144 veterans or active military over a 4 year period at the VA San Diego Healthcare System (VASDHS). Participants will be randomized into one of three groups:

Group A: AtMS Group B: FtMS Group C: Sham-tMS

Individual participation will consist of 12 visits to the VASDHS over the course of 5 months. The visits will be divided into the following phases:

1. PRE-TREATMENT ASSESSMENTS PHASE (weeks 1-2) which consists of Visit 1 (Screening Visit) and Visit 2 (Baseline Assessments) 2. INDUCTION TREATMENT PHASE (weeks 3-4) consists of Visits 3-7 (5 weekday tMS sessions at \>24 and \<72 hours apart); and 3. POST-TREATMENT ASSESSMENTS AND MAINTENANCE TREATMENT PHASE (weeks 6-20) consists of 2 initial biweekly post-induction treatment assessments and maintenance treatments (Visits 8 and 9), and two additional monthly post-induction treatment assessments and maintenance treatments (Visits 10 and 11) and one final study visit (Visit 12)

Вмешательства

• Устройство Transcutaneous magnetic stimulation (tMS)
  Active tMS will be given at different PTP-NP sites with an active tMS coil.
• Устройство Sham transcutaneous magnetic stimulation (Sham-tMS)
  Sham-tMS will be given at different PTP-NP sites with a sham tMS coil. All parameters of the treatment will appear identical to the active treatment.
• Устройство Patient Machine Interface (PMI)
  The PMI will be used to help determine intensities for tMS treatments.

Первичные конечные точки

• Neuropathic Pain Rating [Срок оценки: From enrollment to the end of treatment at 20 weeks]
• Mood [Срок оценки: From baseline to the end of treatment at 20 weeks]
• Quality of Life (Sleep Interference) [Срок оценки: From enrollment to the end of treatment at 20 weeks]
• Functionality - Absenteeism [Срок оценки: From baseline to the end of treatment at 20 weeks]
• Functionality - Presenteeism [Срок оценки: From baseline to the end of treatment at 20 weeks]
• Functionality - Overall work Productivity Impairment [Срок оценки: From baseline to the end of treatment at 20 weeks]
• Functionality - Activity Impairment [Срок оценки: From baseline to the end of treatment at 20 weeks]

Вторичные конечные точки (5)

• Neuropathic Pain Medication Usage [Срок оценки: From enrollment to the end of treatment at 20 weeks]
• Allodynia Area Mapping (Von Frey) [Срок оценки: From baseline to the end of treatment at 20 weeks]
• Allodynia Area Mapping (paint brush) [Срок оценки: From baseline to the end of treatment at 20 weeks]
• QST Temperature Thresholds [Срок оценки: From baseline to end of treatment at 20 weeks]
• von Frey Monofilament Threshold [Срок оценки: From baseline to end of the treatment at 20 weeks]

Критерии участия

Критерии включения

• Veterans (men or women) of any race or ethnicity who are at least 18 years of age
• Chronic peripheral neuropathic pain present for more than 4 months after a traumatic or surgical event per medical history
• Have an average daily Numerical Pain Rating Scale (NPRS) score > 3
• At least one negative or positive sensory sign or symptom confined to innervation territory of the lesioned nervous structure
• Prior diagnostic tests confirming lesion or disease explaining neuropathic

Критерии исключения

• Pregnancy
• Subjects with central neuropathic pain (ex: due to diabetic peripheral neuropathy, HIV, chemo/anti-viral therapy, carpal tunnel syndrome, post-traumatic pain classified as central rather than peripheral)
• Subjects with pain due to Complex Regional Pain Syndrome
• Phantom limb pain after amputation (stump pain and phantom sensation are allowed)
• Subjects with skin conditions in the affected dermatome
• Subjects with other pain such as lumbar or cervical radiculopathy that may confound assessment
• Any subject considered at risk of suicide
• Use of prohibited medications in the absence of appropriate washout periods
• Participation in any other clinical trial within the 30 days prior to screening and/or during participation in this study
• Heart pacemaker
• Subjects with a current diagnosis of DSM-IV-TR Axis I disorder (GAD \& MDD are allowed if clinically stable)
• Subjects with pending lawsuits related to injury
• Subjects who have previously received either transcranial or transcutaneous magnetic stimulation therapy in the past

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Veterans Medical Center - San Diego — San Diego

Идентификаторы

NCT: NCT07301177 · H240010 · HT94252410300

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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