NCT01643798

Brief Summary

Studies have shown that transcranial magnetic stimulation (TMS), a non-invasive form of brain stimulation, can reduce pain in the laboratory and in the clinic. The purpose of this study is to investigate how TMS relieves pain and affects pain circuitry in the brain. One of the primary study hypotheses is that opioid blockade will significantly reduce the pain relief produced by left prefrontal cortex TMS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable pain

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

January 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2012

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

April 15, 2014

Completed
Last Updated

April 15, 2014

Status Verified

June 1, 2012

Enrollment Period

1.3 years

First QC Date

June 22, 2012

Results QC Date

November 18, 2013

Last Update Submit

March 10, 2014

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

  • Pain Rating

    There are two experimental visits separated by one week. During each experiment, pain ratings will be measured every 30 minutes. "Preliminary testing" will be done 30 minutes into the experiment. The purpose of preliminary testing is to select the temperature that will be used to induce pain throughout the experiment. "Baseline testing" will be done 60 minutes into the experiment. "After sham rTMS" will be done 90 minutes into the experiment. "After real rTMS" will be done 120 minutes into the study. The pain scale used in a Visual Analog Scale (VAS). There was an 11-point rating system where "0" represented no pain and "10" represented unbearable pain.

    Baseline (60 minutes into experiment), Post-Sham (90 minutes), Post-Real (120 minutes)

  • Change in BOLD Signal in Pain Processing Regions During Pain, Including Supraspinal Opioidergic Structures

    There are two experimental visits separated by one week. During each experiment, blood oxygen level dependent (BOLD) signal will be measured at baseline (60 minutes into the experiment), post-sham rTMS (90 minutes into the experiment) and post-real (120 minutes into the experiment).

    Baseline (60 minutes into experiment), Post-Sham (90 minutes), Post-Real (120 minutes)

Study Arms (2)

Saline

PLACEBO COMPARATOR

Participants received intravenous saline immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex. The parameters of the stimulation paradigm are as follows: 10 Hz, 5 seconds on, 10 seconds off, 20 minutes, 4000 pulses).

Procedure: Sham rTMSProcedure: Real rTMS

Naloxone

ACTIVE COMPARATOR

Participants received intravenous naloxone (0.1mg/kg) immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex. The parameters of the stimulation paradigm are as follows: 10 Hz, 5 seconds on, 10 seconds off, 20 minutes, 4000 pulses).

Procedure: Sham rTMSProcedure: Real rTMS

Interventions

Sham rTMSPROCEDURE

The eSham system was implemented in conjunction with a specialized Neuronetics sham TMS coil. This coil has a metal plate hidden inside of it that blocks the magnetic field from affecting the brain. Scalp electrodes were used to mimic the feel of real rTMS. This approach has been validated in previous studies.

Also known as: Neuronetics Model 2100 Therapy System
NaloxoneSaline
Real rTMSPROCEDURE

An iron-core, solid-state figure-of-8 coil was used to stimulate the dorsolateral prefrontal cortex. The site of stimulation was estimated using the Beam F3 method based on the 10-20 EEG system.

Also known as: Neuronetics Model 2100 Therapy System
NaloxoneSaline

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers
  • no history of depression or pain
  • no metal in body
  • no medications that lower seizure threshold

You may not qualify if:

  • history of depression or pain
  • history of seizures or epilepsy
  • metal implants in body
  • medications that lower seizure threshold
  • psychiatric medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29414, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Joseph Taylor
Organization
Medical University of South Carolina
taylorjj@musc.edu
8437295729

Study Officials

  • Joseph J Taylor

    Medical University of South Carolina

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2012

First Posted

July 18, 2012

Study Start

January 1, 2011

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

April 15, 2014

Results First Posted

April 15, 2014

Record last verified: 2012-06

Locations

US(1)