Back to resultsTranscranial Magnetic Stimulation (TMS) for CRPS
Primary Purpose
Complex Regional Pain Syndrome (CRPS)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (TMS)
Sponsored by
About this trial
This is an interventional treatment trial for Complex Regional Pain Syndrome (CRPS)
Eligibility Criteria
Inclusion Criteria:
- Age 18 or older
- Diagnosis of CRPS (complex regional pain syndrome)
- Average pain level reported on Numerical Rating Scale meets entry criteria
- Ability to perform the experimental task and procedures.
Exclusion Criteria:
- MRI contraindication (metal implants or devices, claustrophobia)
- TMS Contraindication (eg metal implant or devices near the site of stimulation)
- History of epilepsy
- History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
- Neurologic illness that would interfere with brain integrity
- Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
- Currently pregnant or planning to become pregnant.
- On going legal action or disability claim.
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TMS Intervention for 5 days
TMS Intervention for 1 day
Arm Description
Application of Transcranial Magnetic Stimulation (TMS) for up to 5 days
Application of Transcranial Magnetic Stimulation (TMS) for 1 day
Outcomes
Primary Outcome Measures
Present Pain Intensity
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02067273
Brief Title
Transcranial Magnetic Stimulation (TMS) for CRPS
Official Title
Transcranial Magnetic Stimulation for CRPS
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
Brief Summary
The purpose of this pilot study is to test the durability of response to Transcranial Magnetic Stimulation (TMS) for the symptoms of Complex Regional Pain Syndrome (CRPS). The investigators will test various methods of TMS for varying lengths of time in a pilot study to investigate what the clinical impact.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndrome (CRPS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TMS Intervention for 5 days
Arm Type
Experimental
Arm Description
Application of Transcranial Magnetic Stimulation (TMS) for up to 5 days
Arm Title
TMS Intervention for 1 day
Arm Type
Experimental
Arm Description
Application of Transcranial Magnetic Stimulation (TMS) for 1 day
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation (TMS)
Primary Outcome Measure Information:
Title
Present Pain Intensity
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or older
Diagnosis of CRPS (complex regional pain syndrome)
Average pain level reported on Numerical Rating Scale meets entry criteria
Ability to perform the experimental task and procedures.
Exclusion Criteria:
MRI contraindication (metal implants or devices, claustrophobia)
TMS Contraindication (eg metal implant or devices near the site of stimulation)
History of epilepsy
History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
Neurologic illness that would interfere with brain integrity
Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
Currently pregnant or planning to become pregnant.
On going legal action or disability claim.
Facility Information:
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Links:
URL
http://snapl.stanford.edu
Description
Related Info
Learn more about this trial
Transcranial Magnetic Stimulation (TMS) for CRPS
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