Trial Outcomes & Findings for Transcranial Magnetic Stimulation for Treating Women With Chronic Widespread Pain (NCT NCT00524420)
NCT ID: NCT00524420
Last Updated: 2013-05-23
Results Overview
The BIRS is reliable, valid, and sensitive measure that has been used in a number of studies of analgesics and studies of changes of pain intensity over time and was selected as the primary outcome variable. Each scale is a 20 point scale that has clear anchor points. Patients will be classified as responders if they have a 4 point drop or more on the BIRS. In order to be randomized, subjects were to have had a BIRS score of at least 8. Lower scores indicate less pain and higher scores indicate more pain. This measure was administered once a week at Baseline, at the end of weeks 1, 2, and 3 of TMS treatment, and 1 week post-TMS treatment.
COMPLETED
PHASE2
19 participants
Measured weekly
2013-05-23
Participant Flow
The study was conducted between January 2008 and November 2010. Subjects were recruited from advertisements, referrals, and from a University of Washington clinic that specializes in Fibromyalgia.
493 subjects were screened over the phone. 31 subjects came into the clinic for an initial screening visit. Subjects were allowed to maintain stable doses of medication and psychotherapy. 12 of the screened subjects did not meet criteria for randomization. The remaining 19 were randomized, and 18 completed the study.
Participant milestones
| Measure |
Active rTMS
rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
|
Sham rTMS
Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
11
|
|
Overall Study
COMPLETED
|
7
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Active rTMS
rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
|
Sham rTMS
Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
Baseline Characteristics
Transcranial Magnetic Stimulation for Treating Women With Chronic Widespread Pain
Baseline characteristics by cohort
| Measure |
Active rTMS
n=8 Participants
rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
|
Sham rTMS
n=11 Participants
Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
|
Total
n=19 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
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
54.86 years
STANDARD_DEVIATION 7.65 • n=5 Participants
|
52.09 years
STANDARD_DEVIATION 10.02 • n=7 Participants
|
53.17 years
STANDARD_DEVIATION 9.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured weeklyThe BIRS is reliable, valid, and sensitive measure that has been used in a number of studies of analgesics and studies of changes of pain intensity over time and was selected as the primary outcome variable. Each scale is a 20 point scale that has clear anchor points. Patients will be classified as responders if they have a 4 point drop or more on the BIRS. In order to be randomized, subjects were to have had a BIRS score of at least 8. Lower scores indicate less pain and higher scores indicate more pain. This measure was administered once a week at Baseline, at the end of weeks 1, 2, and 3 of TMS treatment, and 1 week post-TMS treatment.
Outcome measures
| Measure |
Sham rTMS
n=11 Participants
Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
|
Active rTMS
n=7 Participants
rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
|
|---|---|---|
|
Gracely Box Intensity Rating Scale
Baseline
|
13.18 units on a scale
Standard Deviation 2.79
|
14.43 units on a scale
Standard Deviation 2.23
|
|
Gracely Box Intensity Rating Scale
TMS Treatment Week 1
|
10.64 units on a scale
Standard Deviation 3.41
|
13.00 units on a scale
Standard Deviation 3.46
|
|
Gracely Box Intensity Rating Scale
TMS Treatment Week 2
|
10.27 units on a scale
Standard Deviation 3.80
|
11.29 units on a scale
Standard Deviation 4.75
|
|
Gracely Box Intensity Rating Scale
TMS Treatment Week 3
|
8.45 units on a scale
Standard Deviation 5.11
|
10.58 units on a scale
Standard Deviation 6.07
|
|
Gracely Box Intensity Rating Scale
1 Week Post TMS
|
8.60 units on a scale
Standard Deviation 5.56
|
10.50 units on a scale
Standard Deviation 5.96
|
SECONDARY outcome
Timeframe: Measured weeklyThe BURS is reliable, valid, and sensitive measure that has been used in a number of studies of analgesics and studies of changes of pain unpleasantness over time. Each scale is a 20 point scale that has clear anchor points. Pain unpleasantness is different from pain intensity in that it assesses the affective and not the somatic aspect of the pain. Lower scores indicate less unpleasantness of pain and higher scores indicate more unpleasantness of pain. This measure was administered at Baseline, after weeks 1, 2, and 3 of TMS treatment, and 1 week post-TMS.
Outcome measures
| Measure |
Sham rTMS
n=11 Participants
Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
|
Active rTMS
n=7 Participants
rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
|
|---|---|---|
|
Gracely Box Unpleasantness Scale
Baseline
|
9.91 units on a scale
Standard Deviation 2.77
|
12.57 units on a scale
Standard Deviation 1.72
|
|
Gracely Box Unpleasantness Scale
TMS Treatment Week 1
|
8.73 units on a scale
Standard Deviation 3.32
|
11.86 units on a scale
Standard Deviation 4.38
|
|
Gracely Box Unpleasantness Scale
TMS Treatment Week 2
|
9.00 units on a scale
Standard Deviation 3.85
|
10.43 units on a scale
Standard Deviation 4.61
|
|
Gracely Box Unpleasantness Scale
TMS Treatment Week 3
|
7.73 units on a scale
Standard Deviation 4.13
|
9.50 units on a scale
Standard Deviation 6.50
|
|
Gracely Box Unpleasantness Scale
1 Week Post TMS
|
7.60 units on a scale
Standard Deviation 4.84
|
9.83 units on a scale
Standard Deviation 6.05
|
SECONDARY outcome
Timeframe: Measured weeklyThe research coordinator administered the Hamilton Depression Rating Scale-17 item to assess the level of depression on a weekly basis at baseline, weeks 1, 2, 3 of TMS treatment and 1 week post-TMS treatment. Higher scores indicate a higher level of depression. Scores range from 0-50 and scores greater than 20 generally indicate moderate depression. Scores between 0-7 are considered normal.
Outcome measures
| Measure |
Sham rTMS
n=11 Participants
Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
|
Active rTMS
n=7 Participants
rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
|
|---|---|---|
|
Hamilton Depression Rating Scale
Baseline
|
14.64 units on a scale
Standard Deviation 6.34
|
14.71 units on a scale
Standard Deviation 6.55
|
|
Hamilton Depression Rating Scale
TMS Treatment Week 1
|
11.18 units on a scale
Standard Deviation 6.60
|
15.43 units on a scale
Standard Deviation 5.38
|
|
Hamilton Depression Rating Scale
TMS Treatment Week 2
|
9.09 units on a scale
Standard Deviation 5.13
|
11.86 units on a scale
Standard Deviation 5.96
|
|
Hamilton Depression Rating Scale
TMS Treatment Week 3
|
8.36 units on a scale
Standard Deviation 5.01
|
10.83 units on a scale
Standard Deviation 5.78
|
|
Hamilton Depression Rating Scale
1 Week Post TMS
|
7.45 units on a scale
Standard Deviation 4.30
|
8.67 units on a scale
Standard Deviation 6.25
|
SECONDARY outcome
Timeframe: Measured dailyAdverse events (AEs) were collected by open report of emergent symptoms or illness during the study. This form is filled out during baseline, daily before each TMS session by the trained physician administering the TMS, and at each follow-up visit.
Outcome measures
| Measure |
Sham rTMS
n=8 Participants
Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
|
Active rTMS
n=11 Participants
rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
|
|---|---|---|
|
Adverse Events
|
36 number of adverse events
|
35 number of adverse events
|
Adverse Events
Active rTMS
Sham rTMS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active rTMS
n=8 participants at risk
rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
|
Sham rTMS
n=11 participants at risk
Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
|
|---|---|---|
|
Injury, poisoning and procedural complications
pain at the site of stimulation
|
50.0%
4/8
|
27.3%
3/11
|
|
Musculoskeletal and connective tissue disorders
increased muscle aches
|
25.0%
2/8
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
increased fatigue
|
12.5%
1/8
|
9.1%
1/11
|
|
Nervous system disorders
headache
|
62.5%
5/8
|
45.5%
5/11
|
|
Nervous system disorders
insomnia
|
25.0%
2/8
|
9.1%
1/11
|
|
Injury, poisoning and procedural complications
tingling sensation in scalp during stimulation
|
0.00%
0/8
|
9.1%
1/11
|
|
Nervous system disorders
dizziness
|
12.5%
1/8
|
9.1%
1/11
|
|
Nervous system disorders
confusion
|
0.00%
0/8
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
tiredness after session
|
0.00%
0/8
|
9.1%
1/11
|
|
Nervous system disorders
shakiness
|
12.5%
1/8
|
0.00%
0/11
|
|
Psychiatric disorders
anxiety
|
12.5%
1/8
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
lightheadedness after session
|
12.5%
1/8
|
0.00%
0/11
|
|
Psychiatric disorders
poor concentration
|
12.5%
1/8
|
0.00%
0/11
|
|
Psychiatric disorders
"fuzzy-headed" after TMS
|
12.5%
1/8
|
0.00%
0/11
|
|
Nervous system disorders
migraine
|
12.5%
1/8
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
pain in teeth during stimulation
|
0.00%
0/8
|
9.1%
1/11
|
|
Nervous system disorders
drowsiness
|
0.00%
0/8
|
9.1%
1/11
|
|
Psychiatric disorders
feeling more "distant, detached"
|
0.00%
0/8
|
9.1%
1/11
|
|
Psychiatric disorders
flat affect
|
0.00%
0/8
|
9.1%
1/11
|
|
Injury, poisoning and procedural complications
twitching of eye
|
0.00%
0/8
|
9.1%
1/11
|
|
Injury, poisoning and procedural complications
pain in jaw
|
0.00%
0/8
|
9.1%
1/11
|
|
Infections and infestations
sore throat
|
12.5%
1/8
|
9.1%
1/11
|
|
Infections and infestations
coryza
|
12.5%
1/8
|
0.00%
0/11
|
|
Infections and infestations
cough
|
12.5%
1/8
|
9.1%
1/11
|
|
Infections and infestations
sinus headache
|
12.5%
1/8
|
0.00%
0/11
|
|
Infections and infestations
flu
|
25.0%
2/8
|
0.00%
0/11
|
|
Infections and infestations
viral infection
|
12.5%
1/8
|
0.00%
0/11
|
|
Ear and labyrinth disorders
tinnitus
|
12.5%
1/8
|
9.1%
1/11
|
|
Infections and infestations
sinus infection
|
0.00%
0/8
|
9.1%
1/11
|
|
General disorders
dry mouth
|
0.00%
0/8
|
9.1%
1/11
|
|
Infections and infestations
sinus congestion
|
0.00%
0/8
|
9.1%
1/11
|
|
Infections and infestations
sinus drainage
|
0.00%
0/8
|
9.1%
1/11
|
|
Gastrointestinal disorders
nausea
|
25.0%
2/8
|
9.1%
1/11
|
|
Gastrointestinal disorders
abdominal pain
|
25.0%
2/8
|
9.1%
1/11
|
|
Gastrointestinal disorders
diarrhea
|
12.5%
1/8
|
0.00%
0/11
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
sebaceous cyst on thigh
|
12.5%
1/8
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
TMJ pain
|
12.5%
1/8
|
0.00%
0/11
|
|
Cardiac disorders
heart palpitations
|
0.00%
0/8
|
18.2%
2/11
|
|
Eye disorders
dry eyes
|
0.00%
0/8
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
pain in thumb
|
0.00%
0/8
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
pain in shoulder
|
0.00%
0/8
|
9.1%
1/11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place