Trial Outcomes & Findings for rTMS for the Treatment of Chronic Pain in GW1 Veterans (NCT NCT01608321)
NCT ID: NCT01608321
Last Updated: 2017-04-11
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
17 participants
Primary outcome timeframe
Comparison of baseline BPI and end-of-treatment BPI (time 3-4 weeks)
Results posted on
2017-04-11
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
4
|
|
Overall Study
COMPLETED
|
12
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
rTMS for the Treatment of Chronic Pain in GW1 Veterans
Baseline characteristics by cohort
| Measure |
rTMS
n=13 Participants
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
n=4 Participants
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
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
4 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Comparison of baseline BPI and end-of-treatment BPI (time 3-4 weeks)Population: One patient did not meet study entry criteria at baseline (pain scale score = 0), so was not included in the analysis
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.
Outcome measures
| Measure |
rTMS
n=11 Participants
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
n=4 Participants
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
|
|---|---|---|
|
Change in the Brief Pain Inventory (Short Form) Score
|
-1.2 units on a scale
Standard Deviation 1.5
|
-.9 units on a scale
Standard Deviation 1.6
|
Adverse Events
rTMS
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Sham rTMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rTMS
n=13 participants at risk
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
n=4 participants at risk
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
|
|---|---|---|
|
Metabolism and nutrition disorders
hyperglycemia
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
Other adverse events
| Measure |
rTMS
n=13 participants at risk
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
n=4 participants at risk
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
|
|---|---|---|
|
General disorders
headache
|
7.7%
1/13 • Number of events 6
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
hyperglycemia
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place