DoD AtMS for Posttraumatic Peripheral Neuropathic Pain

Official title

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

Overview

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.

Detailed description

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)

Interventions

• Device Transcutaneous magnetic stimulation (tMS)
  Active tMS will be given at different PTP-NP sites with an active tMS coil.
• Device 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.
• Device Patient Machine Interface (PMI)
  The PMI will be used to help determine intensities for tMS treatments.

Primary outcome measures

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

Secondary outcome measures (5)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Veterans Medical Center - San Diego — San Diego

Identifiers

NCT: NCT07301177 · H240010 · HT94252410300

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗