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TMS Treatment for Pain in Chronic Pancreatitis

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ClinicalTrials.gov Identifier: NCT00250484
Recruitment Status : Completed
First Posted : November 8, 2005
Results First Posted : October 21, 2016
Last Update Posted : October 11, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Steven Freedman, Beth Israel Deaconess Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions Idiopathic Chronic Pancreatitis
Pain
Interventions Device: Transcranial Magnetic Stimulation
Device: Sham Transcranial Magnetic Stimulation
Enrollment 23
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description

Active treatment with TMS for 10 days.

Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day

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

Period Title: Overall Study
Started 9 8
Completed 9 8
Not Completed 0 0
Arm/Group Title Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation Total
Hide Arm/Group Description

Active treatment with TMS for 10 days.

Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day

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 of all reporting groups
Overall Number of Baseline Participants 9 8 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 8 participants 17 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
8
 100.0%
17
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 8 participants 17 participants
41.11  (11.27) 46.71  (13.03) 43.5  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 8 participants 17 participants
Female
8
  88.9%
6
  75.0%
14
  82.4%
Male
1
  11.1%
2
  25.0%
3
  17.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 8 participants 17 participants
9 8 17
1.Primary Outcome
Title Pain (Visual Analog Scale, CGI, PGA)
Hide Description 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.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description:

Active treatment with TMS for 10 days.

Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day

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 Number of Participants Analyzed 9 8
Measure Type: Number
Unit of Measure: number of participants w/ reduced pain
7 0
2.Secondary Outcome
Title Cognitive Assessment - Neuropsychological Battery
Hide Description

Beck 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.

Time Frame Baseline and end of treatment at approximately 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description:

Active treatment with TMS for 10 days.

Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day

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 Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
BDI Beck Depression Inventory(baseline) 23.05  (12.55) 22.11  (10.71)
BDI Beck Depression Inventory (after treatment) 18.31  (10.54) 21.69  (12.19)
VAS Visual Analog Scale (baseline) 4.26  (2.7) 6.07  (1.66)
VAS Visual Analog Scale(after treatment) 3.35  (2.27) 7.13  (2.90)
3.Secondary Outcome
Title Medication Use (Medication Diary)
Hide Description Data was not collected or recorded because this outcome measure was no longer considered useful or relevant in the study.
Time Frame Baseline and end of treatment at approximately 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected. Data was not collected or recorded because this outcome measure was no longer considered useful or relevant in the study.
Arm/Group Title Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description:

Active treatment with TMS for 10 days.

Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 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.
Adverse Event Reporting Description Headache, neck pain, scalp burning, hearing difficulties, cognitive changes, changes in concentration, and/or mood changes were assessed.
 
Arm/Group Title Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description

Active treatment with TMS for 10 days.

Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day

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

All-Cause Mortality
Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/9 (44.44%)      2/8 (25.00%)    
Nervous system disorders     
Headache   4/9 (44.44%)  41 2/8 (25.00%)  19
Neck   2/9 (22.22%)  18 1/8 (12.50%)  3
Scalp   1/9 (11.11%)  5 0/8 (0.00%)  0
Seizure   0/9 (0.00%)  0 0/8 (0.00%)  0
Hearing   1/9 (11.11%)  2 0/8 (0.00%)  0
Cognition   2/9 (22.22%)  15 1/8 (12.50%)  13
concentration   2/9 (22.22%)  29 2/8 (25.00%)  30
mood   2/9 (22.22%)  21 2/8 (25.00%)  18
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steven D. Freedman, MD Phd
Organization: Beth Israel Deaconess
Phone: 631-667-2132
EMail: sfreedma@bidmc.harvard.edu
Layout table for additonal information
Responsible Party: Steven Freedman, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00250484     History of Changes
Obsolete Identifiers: NCT00130052
Other Study ID Numbers: 2005P-000259 DK71851
R03DK071851 ( U.S. NIH Grant/Contract )
First Submitted: November 7, 2005
First Posted: November 8, 2005
Results First Submitted: July 20, 2015
Results First Posted: October 21, 2016
Last Update Posted: October 11, 2017