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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Veterans Medical Center - San Diego
RECRUITING
San Diego
Contact Information
Primary
Brandon C Guarini, M.A.
brandon.guarini@va.gov
8586423146
Backup
Caleb T Lopez, B.S.
caleb.lopez@va.gov
8585528585
Time Frame
Start Date: 2025-04-30
Estimated Completion Date: 2029-03
Participants
Target number of participants: 180
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Veterans Medical Research Foundation

This content was sourced from clinicaltrials.gov