Trial Outcomes & Findings for A Pilot Study of TMS Effects on Pain and Depression in Patients With Fibromyalgia (NCT NCT00523302)
NCT ID: NCT00523302
Last Updated: 2018-07-11
Results Overview
To assess each participant's average Pain in the past 24 hours, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up
Results posted on
2018-07-11
Participant Flow
Participant milestones
| Measure |
Active TMS
Participants receive 5 Active TMS treatment sessions per week for two weeks. Active stimulation involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses. Time - 1200 sec = 20 minutes/ session, all days.
Active TMS: Active TMS involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses. Time - 1200 sec = 20 minutes/ session, all days.
|
Sham TMS
Participants receive 5 Sham TMS treatment sessions per week for two weeks. Sham stimulation involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week=20,000 pulses per week, x 2 weeks = 40,000 pulses. Time - 1200 sec = 20 minutes/ session, all days.
Sham TMS: Sham TMS will use the same stimulation frequency for all active subjects (chosen as a priori stimulation based on studies showing antidepressant and anti-nociceptive effects): 10 Hertz - Pulse train duration (on time) 5 seconds, Power (intensity) level 120% of stored motor threshold, Inter-train interval (off time) 10 seconds (15 second cycle time). Additionally, stimulation-train duration and inter-stimulus intervals were determined such that they are in compliance with current published rTMS safety guidelines.
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|---|---|---|
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Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study of TMS Effects on Pain and Depression in Patients With Fibromyalgia
Baseline characteristics by cohort
| Measure |
Active TMS
n=10 Participants
Participants receive 5 Active TMS treatment sessions per week for two weeks. Active stimulation involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses. Time - 1200 sec = 20 minutes/ session, all days.
Active TMS: Active TMS involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses. Time - 1200 sec = 20 minutes/ session, all days.
|
Sham TMS
n=10 Participants
Participants receive 5 Sham TMS treatment sessions per week for two weeks. Sham stimulation involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week=20,000 pulses per week, x 2 weeks = 40,000 pulses. Time - 1200 sec = 20 minutes/ session, all days.
Sham TMS: Sham TMS will use the same stimulation frequency for all active subjects (chosen as a priori stimulation based on studies showing antidepressant and anti-nociceptive effects): 10 Hertz - Pulse train duration (on time) 5 seconds, Power (intensity) level 120% of stored motor threshold, Inter-train interval (off time) 10 seconds (15 second cycle time). Additionally, stimulation-train duration and inter-stimulus intervals were determined such that they are in compliance with current published rTMS safety guidelines.
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Total
n=20 Participants
Total of all reporting groups
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|---|---|---|---|
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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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 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
|
54.20 years
STANDARD_DEVIATION 8.28 • n=5 Participants
|
51.67 years
STANDARD_DEVIATION 18.19 • n=7 Participants
|
53 years
STANDARD_DEVIATION 13.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow upTo assess each participant's average Pain in the past 24 hours, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Outcome measures
| Measure |
Active TMS
n=10 Participants
Since cortical stimulation can be performed non-invasively by active Transcranial Magnetic Stimulation (TMS), Participants in the active TMS group, receive five 20 minute active TMS treatment sessions per week for two weeks. Active TMS uses the active TMS coil to stimulate the cortical area of interest. Active TMS involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses.
|
Sham TMS
n=10 Participants
To prevent unwanted cortical activation, Sham TMS will be employed in the Sham TMS group. For the Sham TMS group, a specially designed sham TMS coil will be used for all sham conditions. This sham TMS coil produces auditory signals identical to active TMS coils but is shielded so that actual stimulation does not occur. This approach is currently the state-of-the-art approach to sham TMS procedures and is employed in high-quality clinical TMS trials. Participants in the sham TMS group receive five 20 minute Sham TMS treatment sessions per week for two weeks.
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|---|---|---|
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Average Pain
Baseline
|
5.60 units on a scale
Standard Deviation 1.85
|
5.43 units on a scale
Standard Deviation 1.82
|
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Average Pain
After Week 1 of Treatment
|
4.90 units on a scale
Standard Deviation 1.89
|
5.49 units on a scale
Standard Deviation 1.90
|
|
Average Pain
After Week 2 of Treatment
|
3.99 units on a scale
Standard Deviation 1.90
|
5.07 units on a scale
Standard Deviation 1.89
|
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Average Pain
1 week post treatment follow up
|
4.19 units on a scale
Standard Deviation 1.90
|
4.76 units on a scale
Standard Deviation 1.90
|
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Average Pain
2 week post treatment follow up
|
4.41 units on a scale
Standard Deviation 1.95
|
5.37 units on a scale
Standard Deviation 2.02
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PRIMARY outcome
Timeframe: Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow upTo assess the impact of fibromyalgia on each participant's function, the FIQ-modified (2002) version will be administered before each study visit. The FIQ-modified (2002) version assesses the following symptoms; physical Impairment, well-being, pain, fatigue, rested, stiffness, anxiety, and depression within the past 24 hours. Each symptom scale ranges from 0 to 10. For example, 0=no pain and 10=extreme pain, 0=not fatigued and 10=extremely fatigued. The final score is the total score which ranges from 0 to 80. Higher scores indicate greater impact of fibromyalgia on functioning.
Outcome measures
| Measure |
Active TMS
n=10 Participants
Since cortical stimulation can be performed non-invasively by active Transcranial Magnetic Stimulation (TMS), Participants in the active TMS group, receive five 20 minute active TMS treatment sessions per week for two weeks. Active TMS uses the active TMS coil to stimulate the cortical area of interest. Active TMS involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses.
|
Sham TMS
n=10 Participants
To prevent unwanted cortical activation, Sham TMS will be employed in the Sham TMS group. For the Sham TMS group, a specially designed sham TMS coil will be used for all sham conditions. This sham TMS coil produces auditory signals identical to active TMS coils but is shielded so that actual stimulation does not occur. This approach is currently the state-of-the-art approach to sham TMS procedures and is employed in high-quality clinical TMS trials. Participants in the sham TMS group receive five 20 minute Sham TMS treatment sessions per week for two weeks.
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|---|---|---|
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THE FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)-Modified
Baseline
|
58.79 units on a scale
Standard Deviation 11.93
|
54.38 units on a scale
Standard Deviation 13.96
|
|
THE FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)-Modified
After Week 1 of Treatment
|
55.03 units on a scale
Standard Deviation 16.93
|
51.22 units on a scale
Standard Deviation 15.96
|
|
THE FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)-Modified
After Week 2 of Treatment
|
42.07 units on a scale
Standard Deviation 18.13
|
51.50 units on a scale
Standard Deviation 17.32
|
|
THE FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)-Modified
1 week Post Treatment follow up
|
49.29 units on a scale
Standard Deviation 19.27
|
43.47 units on a scale
Standard Deviation 16.10
|
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THE FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)-Modified
2 week Post Treatment follow up
|
38.99 units on a scale
Standard Deviation 19.44
|
47.93 units on a scale
Standard Deviation 14.70
|
PRIMARY outcome
Timeframe: Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow upTo assess each participant's level of depression, the HRDS will be administered. The HRDS is a 17-item clinician-rated scale that is designed to evaluate depressed mood, vegetative and cognitive symptoms of depression, and comorbid anxiety symptoms. Eight items are scored on a 5-point scale, ranging from 0-4, where 0=not present and 4=severe. Nine items are scored from 0-2, where 0=None, 1=Mild, and 2=Severe. The final, total score ranges from 0-52. Scores in the range of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression, and scores over 24 are indicative of severe depression.
Outcome measures
| Measure |
Active TMS
n=10 Participants
Since cortical stimulation can be performed non-invasively by active Transcranial Magnetic Stimulation (TMS), Participants in the active TMS group, receive five 20 minute active TMS treatment sessions per week for two weeks. Active TMS uses the active TMS coil to stimulate the cortical area of interest. Active TMS involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses.
|
Sham TMS
n=10 Participants
To prevent unwanted cortical activation, Sham TMS will be employed in the Sham TMS group. For the Sham TMS group, a specially designed sham TMS coil will be used for all sham conditions. This sham TMS coil produces auditory signals identical to active TMS coils but is shielded so that actual stimulation does not occur. This approach is currently the state-of-the-art approach to sham TMS procedures and is employed in high-quality clinical TMS trials. Participants in the sham TMS group receive five 20 minute Sham TMS treatment sessions per week for two weeks.
|
|---|---|---|
|
THE HAMILTON DEPRESSION RATING SCALE (HRDS)
1 week post treatment follow up
|
15.80 units on a scale
Standard Deviation 8.74
|
17.20 units on a scale
Standard Deviation 7.55
|
|
THE HAMILTON DEPRESSION RATING SCALE (HRDS)
2 week post treatment follow up
|
14.10 units on a scale
Standard Deviation 9.42
|
16.40 units on a scale
Standard Deviation 8.18
|
|
THE HAMILTON DEPRESSION RATING SCALE (HRDS)
Baseline
|
21.80 units on a scale
Standard Deviation 7.79
|
17.60 units on a scale
Standard Deviation 7.31
|
|
THE HAMILTON DEPRESSION RATING SCALE (HRDS)
After Week 1 of Treatment
|
17.30 units on a scale
Standard Deviation 8.27
|
17.40 units on a scale
Standard Deviation 8.42
|
|
THE HAMILTON DEPRESSION RATING SCALE (HRDS)
After Week 2 of Treatment
|
16.10 units on a scale
Standard Deviation 8.19
|
15.30 units on a scale
Standard Deviation 7.62
|
Adverse Events
Active TMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham TMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place