- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02067273
Transcranial Magnetic Stimulation (TMS) for CRPS
May 11, 2017 updated by: Sean Mackey, Stanford University
Transcranial Magnetic Stimulation for CRPS
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Palo Alto, California, United States, 94304
- Stanford University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TMS Intervention for 5 days
Application of Transcranial Magnetic Stimulation (TMS) for up to 5 days
|
|
|
Experimental: TMS Intervention for 1 day
Application of Transcranial Magnetic Stimulation (TMS) for 1 day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Present Pain Intensity
Time Frame: Baseline, post-treatment, one week follow-up
|
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.
|
Baseline, post-treatment, one week follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
February 13, 2014
First Submitted That Met QC Criteria
February 18, 2014
First Posted (Estimate)
February 20, 2014
Study Record Updates
Last Update Posted (Actual)
May 15, 2017
Last Update Submitted That Met QC Criteria
May 11, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25894-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Complex Regional Pain Syndrome (CRPS)
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Bo Biering-SoerensenMerz Pharmaceuticals GmbH; The GCP unit at Copenhagen University HospitalRecruitingCRPS (Complex Regional Pain Syndromes) | CRPS Type II | CRPS (Complex Regional Pain Syndrome) Type IDenmark
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AZ DeltaVrije Universiteit BrusselCompletedCRPS (Complex Regional Pain Syndrome) Type IBelgium
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Hospital for Special Surgery, New YorkCompletedCRPS (Complex Regional Pain Syndromes)United States
-
Stanford UniversityCompleted
-
Pôle Saint HélierCompletedCRPS (Complex Regional Pain Syndrome) Type IFrance
-
The Cleveland ClinicMurdoch UniversityTerminatedComplex Regional Pain Syndrome (CRPS)United States
-
Grünenthal GmbHTerminatedComplex Regional Pain Syndrome (CRPS)United States, Australia, France, Germany, Korea, Republic of, New Zealand, Spain
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Vibhor KrishnaMedtronicCompletedComplex Regional Pain Syndrome (CRPS) | Neuropathic Leg PainUnited States
-
Green International UniversityCompletedComplex Regional Pain Syndrome (CRPS) | Shoulder Hand SyndromePakistan
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McMaster UniversityMichael G. DeGroote Institute for Pain Research and Care (IPRC)Not yet recruitingComplex Regional Pain Syndrome (CRPS)Canada
Clinical Trials on Transcranial Magnetic Stimulation (TMS)
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University of ManitobaRecruiting
-
University of PennsylvaniaCompletedAttention Deficit Disorder With Hyperactivity (ADHD)United States
-
Beth Israel Deaconess Medical CenterTerminated
-
Emory UniversityNational Institute of Mental Health (NIMH)Completed
-
VA Office of Research and DevelopmentNot yet recruiting
-
Centre Hospitalier St AnneRecruitingTreatment Resistant SchizophreniaFrance
-
University of California, San DiegoNational Institutes of Health (NIH)CompletedMajor Depressive DisorderUnited States, Australia
-
Northwestern UniversityCompletedHealthyUnited States
-
University of FloridaCompleted
-
Huashan HospitalUnknown