rTMS for the Treatment of Chronic Pain in GW1 Veterans

NCT01608321 | Terminated Phase 3 Results DMC

• 1 other identifier: SPLD-001-11F
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to evaluate the effect of repetitive Transcranial Magnetic Stimulation (rTMS) in the resolution of Chronic Pain. Participants will be Veterans from the first Gulf War (GW1) who often suffer from chronic pain problems.

Conditions

Chronic Pain

Keywords

Chronic Pain; Gulf War Illness; Gulf War Syndrome; Fibromyalgia; repetitive Transcranial Magnetic Stimulation; Transcranial Magnetic Stimulation; Veterans

Outcome Measures

Primary Outcomes (1)

• Change in the Brief Pain Inventory (Short Form) Score

  The Brief Pain Inventory (BPI) is one of the most widely used measurement tools for assessing clinical pain. The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. The basic pain scale rating is a rating of 0-10 with 0 as no pain, and 10 the worst pain imaginable.

  Comparison of baseline BPI and end-of-treatment BPI (time 3-4 weeks)

Study Arms (2)

rTMS

EXPERIMENTAL

Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.

Device: rTMS

Sham rTMS

PLACEBO COMPARATOR

Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.

Device: Sham device

Interventions

rTMS DEVICE

Repetitive Transcranial Magnetic Stimulation

rTMS

Sham device DEVICE

Placebo Device that simulates active rTMS treatment

Sham rTMS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Born between 1936 and 1973 (ages 18 to 55 during Gulf War I) and were deployed to the Persian Gulf during Gulf War I.
• Patients must have symptoms suggestive of Gulf War Illness, including
• Chronic pain \>= 4 on the pain severity scale of the BPI-SF at screening
• At least 2 other symptoms in at least one of the other five (5) categories defined by the 2013 IOM report (Gulf War and Health, Treatment for Chronic Multisymptom Illness): fatigue, mood and cognition, gastrointestinal, respiratory, and neurological
• Ability to obtain a Motor Threshold (MT) will be determined at the end of the screening process.
• If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and patient will be willing to remain on a stable regimen during the acute treatment phase.
• Has an adequately stable condition and environment to enable attendance at scheduled clinic visits.
• For female participants, agrees to use one of the following acceptable methods of birth control:
• Complete abstinence (not having sexual intercourse with anyone)
• An oral contraceptive (birth control pills)
• Norplant
• Depo-Provera
• A condom with spermicide
• A cervical cap with spermicide
• A diaphragm with spermicide

You may not qualify if:

• Unable to be safely withdrawn, at least two-weeks prior to treatment commencement, from medications that substantially increases the risk of having seizures.
• Have a cardiac pacemaker.
• Have an implanted device (deep brain stimulation) or metal in the brain.
• Have a mass lesion, cerebral infarct or other active central nervous system (CNS) disease, including a seizure disorder.
• Known current psychosis as determined by Diagnostic and Statistical Manual (DSM-IV) coding in chart (Axis I, psychotic disorder, schizophrenia) or a history of a non-mood psychotic disorder.
• Diagnosis of Bipolar Affective Disorder (as determined by chart review and intake interview)
• Current amnesic disorders, dementia, Mini Mental Status Exam (MMSE) 24 or delirium.
• Current substance abuse (not including caffeine or nicotine) as determined by positive toxicology screen, or by medical history, within 3 months prior to screening.
• History of loss of consciousness greater than 15 minutes due to head injury.
• Participation in another concurrent clinical trial.
• Patients with prior exposure to rTMS.
• Active current suicidal intent or plan. Patient at risk for suicide will be required to establish a written safety plan involving their primary psychiatrist and the treatment team before entering the clinical trial

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

MeSH Terms

Conditions

Chronic Pain; Persian Gulf Syndrome; Fibromyalgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Occupational Diseases; War-Related Injuries; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Director, WRIISC
• Organization: VA Palo Alto Health Care System

wes.ashford@va.gov

650-493-5000

Study Officials

• John W Ashford, MD PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: rTMS sham involves using the same paddle applied to the head, the side (one shielded internally from the magnetic pulse by aluminum) turned toward the head is randomized. A small shock is also given in both circumstances to disguise the sensation produced by the active rTMS.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Double-blind study of rTMS versus sham

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: May 31, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 11, 2017
• Results First Posted: April 11, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)