Back to resultsTMS for CRPS - Pilot Study
Primary Purpose
Complex Regional Pain Syndrome (CRPS)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
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 Type
Experimental
Arm Label
TMS Intervention - 5 days
Arm Description
Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.
Outcomes
Primary Outcome Measures
Change in Pain
Numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable
Secondary Outcome Measures
Change in Motor Function and Coordination
As assessed by functional capacity exam and physical exam
Change in Sensory Perception
Change in Vasomotor Function
Change in Sudomotor Function
Trophic Changes
Change in Motor Strength and Joint Range of Motion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01926119
Brief Title
TMS for CRPS - Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (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 whether Transcranial Magnetic Stimulation (TMS) may alleviate the symptoms of Complex Regional Pain Syndrome (CRPS). The investigators will test various methods of TMS in a small pilot study to investigate what methods may have clinical potential. This is a small pilot study to determine feasibility and signal to potentially inform future trials.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TMS Intervention - 5 days
Arm Type
Experimental
Arm Description
Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Primary Outcome Measure Information:
Title
Change in Pain
Description
Numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable
Time Frame
Baseline to post-TMS day 5
Secondary Outcome Measure Information:
Title
Change in Motor Function and Coordination
Description
As assessed by functional capacity exam and physical exam
Time Frame
End of 5-day treatment series and at 1-week follow-up relative to baseline
Title
Change in Sensory Perception
Time Frame
End of each treatment session and at 1-week follow-up as compared to baseline
Title
Change in Vasomotor Function
Time Frame
End of each treatment session and at 1-week follow-up as compared to baseline
Title
Change in Sudomotor Function
Time Frame
End of each treatment session and at 1-week follow-up as compared to baseline
Title
Trophic Changes
Time Frame
End of each treatment session and at 1-week follow-up as compared to baseline
Title
Change in Motor Strength and Joint Range of Motion
Time Frame
End of each of the 5 treatment sessions and at 1-week follow-up relative to baseline
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
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