Trial Outcomes & Findings for TMS Treatment for Pain in Chronic Pancreatitis (NCT NCT00250484)
NCT ID: NCT00250484
Last Updated: 2017-10-11
Results Overview
Pain intensity and therefore changes in pain intensity were assessed using a 0-10 Visual Analog Scale where 0 represents the least amount of pain and 10 is the most pain imaginable. The pain evaluation was carried out by a blinded rater based off 1) baseline evaluation: 3 week long pain logs and a diary of pain medication intake, 2) treatment evaluations: participants were also asked to fill out daily pain logs following each TMS session and to keep a diary of pain medications during the CRC stay for the TMS course and 3)follow-up evaluation: finally, there was a follow up measurement 3 weeks after treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
1 year
Results posted on
2017-10-11
Participant Flow
Although 23 participants were recruited for the study, only 17 participated. This discrepancy is a result of 6 participants consenting for a realized exclusion criteria including a history of substance abuse or inability to commit.
Participant milestones
| Measure |
Transcranial Magnetic Stimulation
Active treatment with TMS for 10 days.
Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day
|
Sham Transcranial Magnetic Stimulation
Patients will receive no active TMS/treatment.
Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TMS Treatment for Pain in Chronic Pancreatitis
Baseline characteristics by cohort
| Measure |
Transcranial Magnetic Stimulation
n=9 Participants
Active treatment with TMS for 10 days.
Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day
|
Sham Transcranial Magnetic Stimulation
n=8 Participants
Patients will receive no active TMS/treatment.
Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day
|
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
|
9 Participants
n=5 Participants
|
8 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
|
|
Age, Continuous
|
41.11 years
STANDARD_DEVIATION 11.27 • n=5 Participants
|
46.71 years
STANDARD_DEVIATION 13.03 • n=7 Participants
|
43.5 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPain intensity and therefore changes in pain intensity were assessed using a 0-10 Visual Analog Scale where 0 represents the least amount of pain and 10 is the most pain imaginable. The pain evaluation was carried out by a blinded rater based off 1) baseline evaluation: 3 week long pain logs and a diary of pain medication intake, 2) treatment evaluations: participants were also asked to fill out daily pain logs following each TMS session and to keep a diary of pain medications during the CRC stay for the TMS course and 3)follow-up evaluation: finally, there was a follow up measurement 3 weeks after treatment.
Outcome measures
| Measure |
Transcranial Magnetic Stimulation
n=9 Participants
Active treatment with TMS for 10 days.
Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day
|
Sham Transcranial Magnetic Stimulation
n=8 Participants
Patients will receive no active TMS/treatment.
Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day
|
|---|---|---|
|
Pain (Visual Analog Scale, CGI, PGA)
|
7 number of participants w/ reduced pain
|
0 number of participants w/ reduced pain
|
SECONDARY outcome
Timeframe: Baseline and end of treatment at approximately 1 yearBeck Depression Inventory (BDI), and Visual Analog Scale (VAS) for anxiety were assessed in subjects both as a baseline score before treatment was initiated as and upon conclusion of treatment. BDI is a 0-63 scale increasing with depression severity. A score from 0-13 indicates minimal depression, 14-19 indicates mild depression, 20-28 indicates moderate depression, and 28-63 indicates severe depression. Higher values represent a worse outcome. VAS is a pain assessment ranging from 0-10 increasing with pain severity. High values represent a worse outcome.
Outcome measures
| Measure |
Transcranial Magnetic Stimulation
n=9 Participants
Active treatment with TMS for 10 days.
Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day
|
Sham Transcranial Magnetic Stimulation
n=8 Participants
Patients will receive no active TMS/treatment.
Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day
|
|---|---|---|
|
Cognitive Assessment - Neuropsychological Battery
BDI Beck Depression Inventory(baseline)
|
23.05 units on a scale
Standard Deviation 12.55
|
22.11 units on a scale
Standard Deviation 10.71
|
|
Cognitive Assessment - Neuropsychological Battery
BDI Beck Depression Inventory (after treatment)
|
18.31 units on a scale
Standard Deviation 10.54
|
21.69 units on a scale
Standard Deviation 12.19
|
|
Cognitive Assessment - Neuropsychological Battery
VAS Visual Analog Scale (baseline)
|
4.26 units on a scale
Standard Deviation 2.7
|
6.07 units on a scale
Standard Deviation 1.66
|
|
Cognitive Assessment - Neuropsychological Battery
VAS Visual Analog Scale(after treatment)
|
3.35 units on a scale
Standard Deviation 2.27
|
7.13 units on a scale
Standard Deviation 2.90
|
SECONDARY outcome
Timeframe: Baseline and end of treatment at approximately 1 yearPopulation: Data was not collected. Data was not collected or recorded because this outcome measure was no longer considered useful or relevant in the study.
Data was not collected or recorded because this outcome measure was no longer considered useful or relevant in the study.
Outcome measures
Outcome data not reported
Adverse Events
Transcranial Magnetic Stimulation
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Sham Transcranial Magnetic Stimulation
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transcranial Magnetic Stimulation
n=9 participants at risk
Active treatment with TMS for 10 days.
Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day
|
Sham Transcranial Magnetic Stimulation
n=8 participants at risk
Patients will receive no active TMS/treatment.
Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day
|
|---|---|---|
|
Nervous system disorders
Headache
|
44.4%
4/9 • Number of events 41 • Adverse data were collected up to 30 minutes after rTMS. Adverse effects were assessed using a structured questionnaire listing the most common adverse effects associated with TMS.
Headache, neck pain, scalp burning, hearing difficulties, cognitive changes, changes in concentration, and/or mood changes were assessed.
|
25.0%
2/8 • Number of events 19 • Adverse data were collected up to 30 minutes after rTMS. Adverse effects were assessed using a structured questionnaire listing the most common adverse effects associated with TMS.
Headache, neck pain, scalp burning, hearing difficulties, cognitive changes, changes in concentration, and/or mood changes were assessed.
|
|
Nervous system disorders
Neck
|
22.2%
2/9 • Number of events 18 • Adverse data were collected up to 30 minutes after rTMS. Adverse effects were assessed using a structured questionnaire listing the most common adverse effects associated with TMS.
Headache, neck pain, scalp burning, hearing difficulties, cognitive changes, changes in concentration, and/or mood changes were assessed.
|
12.5%
1/8 • Number of events 3 • Adverse data were collected up to 30 minutes after rTMS. Adverse effects were assessed using a structured questionnaire listing the most common adverse effects associated with TMS.
Headache, neck pain, scalp burning, hearing difficulties, cognitive changes, changes in concentration, and/or mood changes were assessed.
|
|
Nervous system disorders
Scalp
|
11.1%
1/9 • Number of events 5 • Adverse data were collected up to 30 minutes after rTMS. Adverse effects were assessed using a structured questionnaire listing the most common adverse effects associated with TMS.
Headache, neck pain, scalp burning, hearing difficulties, cognitive changes, changes in concentration, and/or mood changes were assessed.
|
0.00%
0/8 • Adverse data were collected up to 30 minutes after rTMS. Adverse effects were assessed using a structured questionnaire listing the most common adverse effects associated with TMS.
Headache, neck pain, scalp burning, hearing difficulties, cognitive changes, changes in concentration, and/or mood changes were assessed.
|
|
Nervous system disorders
Seizure
|
0.00%
0/9 • Adverse data were collected up to 30 minutes after rTMS. Adverse effects were assessed using a structured questionnaire listing the most common adverse effects associated with TMS.
Headache, neck pain, scalp burning, hearing difficulties, cognitive changes, changes in concentration, and/or mood changes were assessed.
|
0.00%
0/8 • Adverse data were collected up to 30 minutes after rTMS. Adverse effects were assessed using a structured questionnaire listing the most common adverse effects associated with TMS.
Headache, neck pain, scalp burning, hearing difficulties, cognitive changes, changes in concentration, and/or mood changes were assessed.
|
|
Nervous system disorders
Hearing
|
11.1%
1/9 • Number of events 2 • Adverse data were collected up to 30 minutes after rTMS. Adverse effects were assessed using a structured questionnaire listing the most common adverse effects associated with TMS.
Headache, neck pain, scalp burning, hearing difficulties, cognitive changes, changes in concentration, and/or mood changes were assessed.
|
0.00%
0/8 • Adverse data were collected up to 30 minutes after rTMS. Adverse effects were assessed using a structured questionnaire listing the most common adverse effects associated with TMS.
Headache, neck pain, scalp burning, hearing difficulties, cognitive changes, changes in concentration, and/or mood changes were assessed.
|
|
Nervous system disorders
Cognition
|
22.2%
2/9 • Number of events 15 • Adverse data were collected up to 30 minutes after rTMS. Adverse effects were assessed using a structured questionnaire listing the most common adverse effects associated with TMS.
Headache, neck pain, scalp burning, hearing difficulties, cognitive changes, changes in concentration, and/or mood changes were assessed.
|
12.5%
1/8 • Number of events 13 • Adverse data were collected up to 30 minutes after rTMS. Adverse effects were assessed using a structured questionnaire listing the most common adverse effects associated with TMS.
Headache, neck pain, scalp burning, hearing difficulties, cognitive changes, changes in concentration, and/or mood changes were assessed.
|
|
Nervous system disorders
concentration
|
22.2%
2/9 • Number of events 29 • Adverse data were collected up to 30 minutes after rTMS. Adverse effects were assessed using a structured questionnaire listing the most common adverse effects associated with TMS.
Headache, neck pain, scalp burning, hearing difficulties, cognitive changes, changes in concentration, and/or mood changes were assessed.
|
25.0%
2/8 • Number of events 30 • Adverse data were collected up to 30 minutes after rTMS. Adverse effects were assessed using a structured questionnaire listing the most common adverse effects associated with TMS.
Headache, neck pain, scalp burning, hearing difficulties, cognitive changes, changes in concentration, and/or mood changes were assessed.
|
|
Nervous system disorders
mood
|
22.2%
2/9 • Number of events 21 • Adverse data were collected up to 30 minutes after rTMS. Adverse effects were assessed using a structured questionnaire listing the most common adverse effects associated with TMS.
Headache, neck pain, scalp burning, hearing difficulties, cognitive changes, changes in concentration, and/or mood changes were assessed.
|
25.0%
2/8 • Number of events 18 • Adverse data were collected up to 30 minutes after rTMS. Adverse effects were assessed using a structured questionnaire listing the most common adverse effects associated with TMS.
Headache, neck pain, scalp burning, hearing difficulties, cognitive changes, changes in concentration, and/or mood changes were assessed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place