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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
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title rTMS Sham rTMS
Hide Arm/Group Description

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

rTMS: Repetitive Transcranial Magnetic Stimulation

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

Period Title: Overall Study
Started 13 4
Completed 12 4
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title rTMS Sham rTMS Total
Hide Arm/Group Description

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

rTMS: Repetitive Transcranial Magnetic Stimulation

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 of all reporting groups
Overall Number of Baseline Participants 13 4 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 4 participants 17 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 4 participants 17 participants
Female
3
  23.1%
0
   0.0%
3
  17.6%
Male
10
  76.9%
4
 100.0%
14
  82.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 4 participants 17 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 4 participants 17 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 4 participants 17 participants
13 4 17
1.Primary Outcome
Title Change in the Brief Pain Inventory (Short Form) Score
Hide Description 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.
Time Frame Comparison of baseline BPI and end-of-treatment BPI (time 3-4 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One patient did not meet study entry criteria at baseline (pain scale score = 0), so was not included in the analysis
Arm/Group Title rTMS Sham rTMS
Hide Arm/Group Description:

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

rTMS: Repetitive Transcranial Magnetic Stimulation

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

Overall Number of Participants Analyzed 11 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.2  (1.5) -.9  (1.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title rTMS Sham rTMS
Hide Arm/Group Description

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

rTMS: Repetitive Transcranial Magnetic Stimulation

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

All-Cause Mortality
rTMS Sham rTMS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
rTMS Sham rTMS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      0/4 (0.00%)    
Metabolism and nutrition disorders     
hyperglycemia * 1 [1]  1/13 (7.69%)  1 0/4 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, yperglycemia
[1]
Elevated blood glucose = 600, considered unrelated to treatment.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
rTMS Sham rTMS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/13 (15.38%)      0/4 (0.00%)    
General disorders     
headache * 1 [1]  1/13 (7.69%)  6 0/4 (0.00%)  0
Metabolism and nutrition disorders     
hyperglycemia * 2 [2]  1/13 (7.69%)  1 0/4 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, headache
2
Term from vocabulary, hyperglycemia
[1]
post-rTMS headache
[2]
blood sugar = 153 (known diabetic)
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
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