rTMS for the Treatment of Chronic Pain in GW1 Veterans (rTMS)
|ClinicalTrials.gov Identifier: NCT01608321|
Recruitment Status : Terminated (Did not meet recruitment goals)
First Posted : May 31, 2012
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Device: rTMS Device: Sham device||Phase 3|
A number of studies have been conducted on the health of Veterans deployed to Iraq during GW1. The focus of these studies has been primarily to define the nature of symptoms and symptom clusters and to determine if evidence supports the definition of a new unique illness. Most noteworthy is the "Iowa Study", a cross-sectional study of 3,695 Veterans from Iowa consisting of those who were and were not deployed in GW1. In telephone interviews the Gulf War deployed Veterans reported approximately twice the number of symptoms compared to those who were not deployed.
The often ambiguous and seemingly treatment resistant symptoms presented by GW1 Veterans represent a challenge to the Veteran's Affairs Health Care System on two fronts; efficacy in treatment and cost. In particular, unlike most medical conditions which can be diagnosed by objective medical findings, pain is a subjective experience (International Association for the Study of Pain, 1994). Therefore the investigators propose to engage in a clinical trial of rTMS in chronic pain that occurs in the context of multiple medical symptoms in the GW1 population. The symptom category approach will be applied with the restriction that enrolled GWI diagnosed patients will have symptoms of chronic pain as outlined in the musculoskeletal category and at least two additional symptoms.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind study of rTMS versus sham|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||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.|
|Official Title:||rTMS for the Treatment of Chronic Pain in GW1 Veterans|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||September 2015|
Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.
Repetitive Transcranial Magnetic Stimulation
Placebo Comparator: Sham rTMS
Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.
Device: Sham device
Placebo Device that simulates active rTMS treatment
- Change in the Brief Pain Inventory (Short Form) Score [ Time Frame: Comparison of baseline BPI and end-of-treatment BPI (time 3-4 weeks) ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608321
|United States, California|
|VA Palo Alto Health Care System, Palo Alto, CA|
|Palo Alto, California, United States, 94304-1290|
|Principal Investigator:||John W Ashford, MD PhD||VA Palo Alto Health Care System, Palo Alto, CA|