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Trial record 58 of 133 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)
Enrollment 20

Recruitment Details  
Pre-assignment Details  
Arm/Group Title TMS Intervention for 1 Day TMS Intervention for 5 Days
Hide Arm/Group Description

Application of Transcranial Magnetic Stimulation (TMS) for 1 day

Transcranial Magnetic Stimulation (TMS)

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

Transcranial Magnetic Stimulation (TMS)

Period Title: Overall Study
Started 5 15
Completed 5 12
Not Completed 0 3
Arm/Group Title TMS Intervention for 1 Day TMS Intervention for 5 Days Total
Hide Arm/Group Description

Application of Transcranial Magnetic Stimulation (TMS) for 1 day

Transcranial Magnetic Stimulation (TMS)

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

Transcranial Magnetic Stimulation (TMS)

Total of all reporting groups
Overall Number of Baseline Participants 5 12 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 12 participants 17 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]
Measure Analysis Population Description: Only data from participants who completed the study were analyzed.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 12 participants 17 participants
49.8  (16.47) 42.92  (13.69) 44.94  (14.39)
[1]
Measure Description: Only data from participants who completed the study were analyzed.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 12 participants 17 participants
Female
4
  80.0%
12
 100.0%
16
  94.1%
Male
1
  20.0%
0
   0.0%
1
   5.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 12 participants 17 participants
5 12 17
1.Primary Outcome
Title Present Pain Intensity
Hide Description Present pain intensity was reported by participants using a visual analog scale (VAS) from scores ranging from 1-10; lower scores represent less pain, higher scores represent more severe pain.
Time Frame Baseline, post-treatment, one week follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data from participants who completed the study were analyzed.
Arm/Group Title TMS Intervention (1 Day) TMS Intervention (5 Days)
Hide Arm/Group Description:

Application of Transcranial Magnetic Stimulation (TMS) for 1 day

Transcranial Magnetic Stimulation (TMS)

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

Transcranial Magnetic Stimulation (TMS)

Overall Number of Participants Analyzed 5 12
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 6.5  (2.3) 6.3  (1.4)
Post-treatment 3.1  (3.1) 3.7  (3.0)
One week follow-up 4.6  (4.0) 4.3  (2.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TMS Intervention for 1 Day TMS Intervention for 5 Days
Hide Arm/Group Description

Application of Transcranial Magnetic Stimulation (TMS) for 1 day

Transcranial Magnetic Stimulation (TMS)

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

Transcranial Magnetic Stimulation (TMS)

All-Cause Mortality
TMS Intervention for 1 Day TMS Intervention for 5 Days
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/15 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
TMS Intervention for 1 Day TMS Intervention for 5 Days
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TMS Intervention for 1 Day TMS Intervention for 5 Days
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      10/15 (66.67%)    
General disorders     
Headache   1/5 (20.00%)  1 7/15 (46.67%)  7
Muscle spasms   0/5 (0.00%)  2/15 (13.33%)  2
Procedural discomfort   0/5 (0.00%)  1/15 (6.67%)  1
Increased pain   0/5 (0.00%)  2/15 (13.33%)  2
Neck pain   0/5 (0.00%)  2/15 (13.33%)  2
Nausea   0/5 (0.00%)  1/15 (6.67%)  1
Gingival pain   0/5 (0.00%)  1/15 (6.67%)  1
Fatigue   0/5 (0.00%)  1/15 (6.67%)  1
Indicates events were collected by systematic assessment
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
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