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Trial record 58 of 130 for:    Complex Regional Pain Syndrome

Transcranial Magnetic Stimulation (TMS) for CRPS

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ClinicalTrials.gov Identifier: NCT02067273
Recruitment Status : Completed
First Posted : February 20, 2014
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Complex Regional Pain Syndrome (CRPS)
Intervention: Device: Transcranial Magnetic Stimulation (TMS)

  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
No text entered.

Reporting Groups
  Description
TMS Intervention for 1 Day

Application of Transcranial Magnetic Stimulation (TMS) for 1 day

Transcranial Magnetic Stimulation (TMS)

TMS Intervention for 5 Days

Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days

Transcranial Magnetic Stimulation (TMS)


Participant Flow:   Overall Study
    TMS Intervention for 1 Day   TMS Intervention for 5 Days
STARTED   5   15 
COMPLETED   5   12 
NOT COMPLETED   0   3 



  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
TMS Intervention for 1 Day

Application of Transcranial Magnetic Stimulation (TMS) for 1 day

Transcranial Magnetic Stimulation (TMS)

TMS Intervention for 5 Days

Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days

Transcranial Magnetic Stimulation (TMS)

Total Total of all reporting groups

Baseline Measures
   TMS Intervention for 1 Day   TMS Intervention for 5 Days   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   12   17 
Age [1] 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      4  80.0%      11  91.7%      15  88.2% 
>=65 years      1  20.0%      1   8.3%      2  11.8% 
[1] Only data from participants who completed the study were analyzed.
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 49.8  (16.47)   42.92  (13.69)   44.94  (14.39) 
[1] Only data from participants who completed the study were analyzed.
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  80.0%      12 100.0%      16  94.1% 
Male      1  20.0%      0   0.0%      1   5.9% 
Region of Enrollment 
[Units: Participants]
     
United States   5   12   17 


  Outcome Measures

1.  Primary:   Present Pain Intensity   [ Time Frame: Baseline, post-treatment, one week follow-up ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab
Organization: Stanford University School of Medicine
phone: (650) 498-6477
e-mail: smackey@stanford.edu



Responsible Party: Sean Mackey, Stanford University
ClinicalTrials.gov Identifier: NCT02067273     History of Changes
Other Study ID Numbers: 25894-2
First Submitted: February 13, 2014
First Posted: February 20, 2014
Results First Submitted: April 3, 2017
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017