Improving Functions in Veterans With Post-traumatic Peripheral Neuropathic Pain

NCT02979925 | Completed Results DMC FDA Device

• 2 other identifiers: B2366-P1192133
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will set the foundation for future multi-center studies. To validate tMS as a non-contact and non-invasive pain treatment option for reducing pain in Veterans with PTP-NP and improving their overall functions.

Conditions

Neuropathic Pain

Keywords

neuropathic pain; TMS; nerve injury; transcutaneous magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Evaluation of Spontaneous Pain Scores

  Spontaneous pain rating: Spontaneous pain level will be measured by using a sliding algometer, known as the Mechanical Visual Analog Scale (M-VAS). The device has been well validated, and is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable." The corresponding length of the red bar with a scale from 0 to 100, which can be read on the back by the tester, represents the subject's intensity of pain. 0 represents "no pain sensation" and 100 represents "the most intense pain sensation imaginable." A lower value indicates a better outcome with lower levels of pain reported.

  Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.

Secondary Outcomes (2)

• Evaluation of Evoked Pain Scores: Stroking

  Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.

• Evaluation of Evoked Pain Scores: Von Frey

  Assessed during each of the subject's baseline visit, 1 week post treatment visit, and 4 weeks post treatment visit.

Study Arms (2)

Active transcutaneous magnetic stimulation

EXPERIMENTAL

Active transcutaneous magnetic stimulation (TMS) at the target site of nerve damage/injury.

Device: Active Transcutaneous Magnetic Stimulation

Sham transcutaneous magnetic stimulation

SHAM COMPARATOR

Sham TMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.

Device: Sham Transcutaneous Magnetic Stimulation

Interventions

Active Transcutaneous Magnetic Stimulation DEVICE

Active transcutaneous magnetic stimulation (TMS) at the target site of nerve damage/injury.

Also known as: TMS

Active transcutaneous magnetic stimulation

Sham Transcutaneous Magnetic Stimulation DEVICE

Sham TMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.

Also known as: TMS

Sham transcutaneous magnetic stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
• Subject is willing and able to comply with scheduled visits, treatment plan, daily pain, sleep and all study related assessments and procedures
• Subjects must be literate in the language used in the assessments and pain diary
• Veterans (men or women) of any race or ethnicity who are at least 18 years of age
• Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 7 days after the last session of the assigned treatment
• A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active
• Subject must have chronic peripheral neuropathic pain present for more than 4 months after a traumatic or surgical event per medical history, this may include, for example:
• motor vehicle accident
• fall
• sports injury
• knee or hip replacement
• hernia repair
• thoracotomy
• mastectomy
• focal/localized burns or crush injury

You may not qualify if:

• Subjects presenting with ANY of the following will NOT be included in the study:
• Subjects with neuropathic pain due to:
• diabetic peripheral neuropathy
• post herpetic neuralgia
• Human Immunodeficiency Virus
• chemo/anti-viral therapy
• trigeminal neuralgia
• carpal tunnel syndrome
• subjects whose post-traumatic neuropathic pain is categorized as central (e.g., spinal cord injury) rather than peripheral
• Subjects with pain due to Complex Regional Pain Syndrome (CRPS, Type I or Type II)
• Phantom limb pain after amputation. However, subjects with stump pain and phantom sensation but no phantom pain will not be excluded
• Subjects with skin conditions in the affected dermatome that in the judgment of the investigator can interfere with evaluation of the neuropathic pain condition
• Subjects with other pain such as lumbar or cervical radiculopathy that may confound assessment or self-evaluation of the peripheral neuropathic pain
• subjects with significant somatic pain at the site of their trauma that may confound assessment or self-evaluation of their neuropathic pain
• Any subject considered at risk of suicide or self-harm based on investigator judgment and/or the details of a risk assessment

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

One limitation of this study is small sample size. In addition, the location of nerve damage (whether it is extremities or truncal region) could be a confounding factor for the effectiveness of the treatment.

Results Point of Contact

• Title: Albert Leung, MD
• Organization: VA San Diego Healthcare System

albert.leung@va.gov

858-552-8585

Study Officials

• Albert Yick Leung, MD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 2, 2016
• Study Start: November 1, 2016
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: July 12, 2021
• Results First Posted: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)