NCT02067273

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

May 15, 2017

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

February 13, 2014

Results QC Date

April 3, 2017

Last Update Submit

May 11, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Present Pain Intensity

    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

Study Arms (2)

TMS Intervention for 5 days

EXPERIMENTAL

Application of Transcranial Magnetic Stimulation (TMS) for up to 5 days

Device: Transcranial Magnetic Stimulation (TMS)

TMS Intervention for 1 day

EXPERIMENTAL

Application of Transcranial Magnetic Stimulation (TMS) for 1 day

Device: Transcranial Magnetic Stimulation (TMS)

Interventions

TMS Intervention for 1 dayTMS Intervention for 5 days

Eligibility Criteria

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

You may qualify if:

  • 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.

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 University School of Medicine

Palo Alto, California, 94304, United States

Location

Related Links

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

Results Point of Contact

Title
Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab
Organization
Stanford University School of Medicine

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Pain Medicine

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 20, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

May 15, 2017

Results First Posted

May 15, 2017

Record last verified: 2017-05

Locations