TMS for CRPS - Pilot Study

NCT ID: NCT01926119

Last Updated: 2017-05-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Complex Regional Pain Syndrome (CRPS)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TMS Intervention - 5 days

Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type DEVICE

Interventions

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Transcranial Magnetic Stimulation

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Sean Mackey

Chief, Division of Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University School of Medicine

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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25894

Identifier Type: -

Identifier Source: org_study_id

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