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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Transcranial Magnetic Stimulation   Sham Transcranial Magnetic Stimulation
STARTED   9   8 
COMPLETED   9   8 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   Transcranial Magnetic Stimulation   Sham Transcranial Magnetic Stimulation   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 9   8   17 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation) 		 41.11  (11.27)   46.71  (13.03)   43.5  (11.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      8  88.9%      6  75.0%      14  82.4% 
Male      1  11.1%      2  25.0%      3  17.6% 
Region of Enrollment 
[Units: Participants]
 		     
United States   9   8   17 


  Outcome Measures

1.  Primary:   Pain (Visual Analog Scale, CGI, PGA)   [ Time Frame: 1 year ]
  Show Outcome Measure 1

2.  Secondary:   Cognitive Assessment - Neuropsychological Battery   [ Time Frame: Baseline and end of treatment at approximately 1 year ]
  Show Outcome Measure 2

3.  Secondary:   Medication Use (Medication Diary)   [ Time Frame: Baseline and end of treatment at approximately 1 year ]
  Show Outcome Measure 3


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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:  
Name/Title: Steven D. Freedman, MD Phd
Organization: Beth Israel Deaconess
phone: 631-667-2132
e-mail: sfreedma@bidmc.harvard.edu



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