Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

TMS Treatment for Pain in Chronic Pancreatitis

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Steven Freedman, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00250484
First received: November 7, 2005
Last updated: August 30, 2016
Last verified: August 2016
Results First Received: July 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Conditions: Idiopathic Chronic Pancreatitis
Pain
Interventions: Device: Transcranial Magnetic Stimulation
Device: Sham Transcranial Magnetic Stimulation

  Participant Flow
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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
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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]
     
<=18 years   0   0   0 
Between 18 and 65 years   9   8   17 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.11  (11.27)   46.71  (13.03)   43.5  (11.9) 
Gender 
[Units: Participants]
     
Female   8   6   14 
Male   1   2   3 
Region of Enrollment 
[Units: Participants]
     
United States   9   8   17 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Cognitive Assessment - Neuropsychological Battery   [ Time Frame: 1 year ]

3.  Secondary:   Medication Use (Medication Diary)   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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 ( US NIH Grant/Contract Award Number )
Study First Received: November 7, 2005
Results First Received: July 20, 2015
Last Updated: August 30, 2016
Health Authority: United States: Federal Government