Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2025-04-30
2029-03-31
Brief Summary
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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
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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)
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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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.
Transcutaneous magnetic stimulation (tMS)
Active tMS will be given at different PTP-NP sites with an active tMS coil.
Patient Machine Interface (PMI)
The PMI will be used to help determine intensities for tMS treatments.
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.
Transcutaneous magnetic stimulation (tMS)
Active tMS will be given at different PTP-NP sites with an active tMS coil.
Patient Machine Interface (PMI)
The PMI will be used to help determine intensities for tMS treatments.
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.
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.
Patient Machine Interface (PMI)
The PMI will be used to help determine intensities for tMS treatments.
Interventions
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Transcutaneous magnetic stimulation (tMS)
Active tMS will be given at different PTP-NP sites with an active tMS coil.
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.
Patient Machine Interface (PMI)
The PMI will be used to help determine intensities for tMS treatments.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Veterans Medical Research Foundation
OTHER
Responsible Party
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Principal Investigators
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Albert Y Leung, M.D.
Role: PRINCIPAL_INVESTIGATOR
Veterans Medical Research Foundation (VMRF)
Locations
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Veterans Medical Center - San Diego
San Diego, California, United States
Countries
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Central Contacts
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Facility Contacts
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Brandon C Guarini, M.A.
Role: primary
Caleb T Lopez, B.S.
Role: backup
Other Identifiers
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HT94252410300
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H240010
Identifier Type: -
Identifier Source: org_study_id