NCT03137472

Brief Summary

The aim of the current study is to assess the efficacy of TMS in the treatment of Complex Regional Pain Syndrome (CRPS). It is hypothesized that participants who receive TMS (Group 1) relative to sham treatment (Group 2) once daily for two days will demonstrate a greater improvement in CRPS-related pain and other associated symptomology (i.e., cognitive, emotional and physical) compared to baseline. Participants will be followed until they reach their baseline for two consecutive weeks to assess safety and duration of symptom alleviation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Apr 2017Jun 2026

Study Start

First participant enrolled

April 24, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 2, 2017

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2026

Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

9.2 years

First QC Date

April 28, 2017

Last Update Submit

May 12, 2025

Conditions

Keywords

TMS, CRPS, Sham

Outcome Measures

Primary Outcomes (2)

  • Change in Pain

    Decrease in CRPS-related Pain Ratings

    1 week follow-up compared to baseline

  • Duration of Pain Relief

    Duration of decreased CRPS-related pain ratings, measured as a length of time until pain returns for two consecutive weeks

    Duration from last treatment until pain returns - up to an estimate of 6 months

Secondary Outcomes (1)

  • Change in Pain-related Symptomology

    Duration from last treatment until pain returns - up to an estimate of 6 months

Study Arms (2)

Active Treatment

EXPERIMENTAL

Participants will receive active TMS in the target area once daily for two days

Device: Transcranial Magnetic Stimulation (TMS)

Sham Treatment

SHAM COMPARATOR

Participants will receive active TMS in a non-target area once daily for two days

Device: Transcranial Magnetic Stimulation (TMS)

Interventions

The Magventure TMS stimulator will be used to perform intermittent theta burst followed by high frequency Transcranial Magnetic Stimulation (TMS).

Active TreatmentSham Treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70
  • Diagnosis of CRPS (complex regional pain syndrome) for at least 3 months
  • Average pain level reported on Numerical Rating Scale meets entry criteria
  • Ability to perform the experimental task and procedures.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Pain Management Center

Redwood City, California, 94043, United States

RECRUITING

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single, blinding of participant
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Pain Medicine

Study Record Dates

First Submitted

April 28, 2017

First Posted

May 2, 2017

Study Start

April 24, 2017

Primary Completion (Estimated)

June 29, 2026

Study Completion (Estimated)

June 29, 2026

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations