DoD AtMS for Posttraumatic Peripheral Neuropathic Pain

Part of paid clinical trials in San Diego, California.

Sponsor
Veterans Medical Research Foundation
Study ID
NCT07301177
Status
Recruiting
Apply to this trial

Conditions

  • Peripheral Neuropathy
  • Peripheral Neuropathy Due to Physical Trauma
  • Peripheral Neuropathy Due to Surgical Trauma
  • Posttraumatic Peripheral Neuropathic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 30, 2025
Status verified
Jul 2025
Primary completion
Nov 30, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Adaptive transcutaneous magnetic stimulation (AtMS)
    The adaptive transcutaneous magnetic stimulation (AtMS) arm uses a patient machine interface (PMI) to determine what intensity to set the study tMS treatments. Treatment is then performed with an active tMS coil.
  • Active Comparator: Fixed transcutaneous magnetic stimulation (FtMS)
    The fixed transcutaneous magnetic stimulation (FtMS) arm uses a patient machine interface (PMI) to determine an intensity which is then multiplied by 1.5 during the first treatment session. This calculated intensity is used for every treatment session going forward, although the subject will still engage with the PMI every session. Treatments are performed using an active tMS coil.
  • Sham Comparator: Sham transcutaneous magnetic stimulation (Sham-tMS)
    The sham transcutaneous magnetic stimulation (Sham-tMS) arm uses the patient machine interface (PMI) to determine the intensity to set the study tMS treatments for each visit. Treatment is performed using a sham tMS coil that sounds and feels the same.

Primary Outcome Measure

Neuropathic Pain Rating [ Time Frame: From enrollment to the end of treatment at 20 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Veterans Medical Center - San DiegoSan DiegoCalifornia92161
Brandon C Guarini, M.A.
[email protected]
858-642-3146
Caleb T Lopez, B.S.
[email protected]
8585528585
Albert Y Leung, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Diego, CA

By research site
Veterans Medical Center - San Diego· San Diego, CA

Related Studies