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rTMS for the Treatment of Chronic Pain in GW1 Veterans (rTMS)

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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
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Chronic Pain
Interventions: Device: rTMS
Device: Sham device

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
rTMS

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

rTMS: Repetitive Transcranial Magnetic Stimulation

Sham rTMS

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

Sham device: Placebo Device that simulates active rTMS treatment


Participant Flow:   Overall Study
    rTMS   Sham rTMS
STARTED   13   4 
COMPLETED   12   4 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
rTMS

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

rTMS: Repetitive Transcranial Magnetic Stimulation

Sham rTMS

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

Sham device: Placebo Device that simulates active rTMS treatment

Total Total of all reporting groups

Baseline Measures
   rTMS   Sham rTMS   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   4   17 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      13 100.0%      4 100.0%      17 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  23.1%      0   0.0%      3  17.6% 
Male      10  76.9%      4 100.0%      14  82.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      3  23.1%      0   0.0%      3  17.6% 
Not Hispanic or Latino      10  76.9%      4 100.0%      14  82.4% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3  23.1%      1  25.0%      4  23.5% 
White      10  76.9%      3  75.0%      13  76.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   13   4   17 


  Outcome Measures

1.  Primary:   Change in the Brief Pain Inventory (Short Form) Score   [ Time Frame: Comparison of baseline BPI and end-of-treatment BPI (time 3-4 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Director, WRIISC
Organization: VA Palo Alto Health Care System
phone: 650-493-5000
e-mail: wes.ashford@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01608321     History of Changes
Other Study ID Numbers: SPLD-001-11F
First Submitted: May 25, 2012
First Posted: May 31, 2012
Results First Submitted: December 12, 2016
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017