NCT00349050

Brief Summary

The purpose of this study is to investigate the effects of transcranial magnetic stimulation on pain perception.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2006

Longer than P75 for phase_2 pain

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 1, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

April 30, 2012

Status Verified

October 1, 2010

Enrollment Period

4.3 years

First QC Date

July 5, 2006

Last Update Submit

April 26, 2012

Conditions

Keywords

trigeminal neuralgianeuropathic paincomplex regional pain syndromereflex sympathetic dystrophypainchronic paintranscranial magnetic stimulationTMSlaboratory pain assessment

Outcome Measures

Primary Outcomes (1)

  • Clinical neuropathic pain ratings, activity levels, analgesic medication usage, mood ratings, laboratory pain measures (thermal and mechanical pain thresholds, suprathreshold pain ratings, and wind-up pain ratings).

    measured during the study period

Study Arms (2)

1

ACTIVE COMPARATOR

laboratory pain assessment

Device: laboratory pain assessment

2

ACTIVE COMPARATOR

transcranial magnetic stimulation

Procedure: transcranial magnetic stimulation

Interventions

Participants will record their pain experiences every day for 2 weeks before receiving the first of 5 laboratory pain assessments. The laboratory pain assessment uses a small device, controlled by a computer and attached to the underside of the forearm, to produce different temperature stimulations. As the device reaches a level considered painful to the participant, he/she can push a button to return to a level of comfort.

1

There will be two, 20-minute, 3-day TMS treatment sessions. Participants will be randomly assigned to one of two groups. Group A will receive real TMS for the first 3-day treatment and "sham" TMS (which does not involve real stimulation) for the second treatment. Group B will receive "sham" TMS for the first treatment, and real TMS for the second treatment. Regardless of the group, participants will receive both real and "sham" TMS.

2

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • For Healthy Adults:
  • Between age of 21 and 60
  • No prescription medications in previous 3 months
  • No seizure history
  • No depression
  • Not suicidal
  • No anxiety
  • No hospitalizations or surgeries in previous 6 months
  • No history of chronic pain conditions
  • No implanted metal devices (e.g., pacemakers, metal plates, wires)
  • Not pregnant
  • No alcohol abuse/dependence history in previous 6 months
  • No illicit drug use in previous 6 months
  • Capable of reading, writing, giving consent, following instructions
  • No history of brain surgery or history of loss of consciousness \>15 minutes
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences Medical University of South Carolina 5-North, IOP, 67 President Street

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

PainTrigeminal NeuralgiaNeuralgiaComplex Regional Pain SyndromesReflex Sympathetic DystrophyChronic Pain

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTrigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Jeffrey J. Borckardt, Ph.D.

    Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 6, 2006

Study Start

July 1, 2006

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

April 30, 2012

Record last verified: 2010-10

Locations