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

Veterans Medical Research Foundation

Status: Enrolling

Conditions: Peripheral Neuropathy; Peripheral Neuropathy Due to Physical Trauma; Posttraumatic Peripheral Neuropathic Pain; Peripheral Neuropathy Due to Surgical Trauma

Treatments: Device: Sham transcutaneous magnetic stimulation (Sham-tMS); Device: Transcutaneous magnetic stimulation (tMS); Device: Patient Machine Interface (PMI)

Study type: Interventional

Funder types: Other

Identifiers

NCT07301177

HT94252410300 (Other Grant/Funding Number)

H240010

Details and patient eligibility

About

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.

Full 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)

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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180 participants in 3 patient groups

Adaptive transcutaneous magnetic stimulation (AtMS)

Active Comparator group

Description:

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.

Treatment:

Device: Patient Machine Interface (PMI)

Device: Transcutaneous magnetic stimulation (tMS)

Fixed transcutaneous magnetic stimulation (FtMS)

Active Comparator group

Description:

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.

Treatment:

Device: Patient Machine Interface (PMI)

Device: Transcutaneous magnetic stimulation (tMS)

Sham transcutaneous magnetic stimulation (Sham-tMS)

Sham Comparator group

Description:

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.

Treatment:

Device: Patient Machine Interface (PMI)

Device: Sham transcutaneous magnetic stimulation (Sham-tMS)