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TMS 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
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndrome (CRPS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 or older
  2. Diagnosis of CRPS (complex regional pain syndrome)
  3. Average pain level reported on Numerical Rating Scale meets entry criteria
  4. Ability to perform the experimental task and procedures.

Exclusion Criteria:

  1. MRI contraindication (metal implants or devices, claustrophobia)
  2. TMS Contraindication (eg metal implant or devices near the site of stimulation)
  3. History of epilepsy
  4. History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
  5. Neurologic illness that would interfere with brain integrity
  6. Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
  7. Currently pregnant or planning to become pregnant.
  8. 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

First Posted
August 16, 2013
Last Updated
March 30, 2017
Sponsor
Stanford University
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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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TMS for CRPS - Pilot Study

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