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Role of the Supraspinal Opioidergic Circuit in Prefrontal TMS-Induced Analgesia

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01643798
First received: June 22, 2012
Last updated: July 16, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Pain
 Procedure: sham or real rTMS
Drug: saline or naloxone pretreatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Role of the Supraspinal Opioidergic Circuit in Prefrontal TMS-Induced Analgesia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • change in pain rating [ Time Frame: every 30 minutes ] [ Designated as safety issue: No ]
    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 this 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.

  • change in BOLD signal in pain processing regions during pain, including supraspinal opioidergic structures [ Time Frame: every 30 minutes ] [ Designated as safety issue: No ]
    There are two experimental visits separated by one week. During each experiment, BOLD signal will be measured every 30 minutes. "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.


Enrollment: 15
Study Start Date: January 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Real rTMS
Real rTMS
 Procedure: sham or real rTMS
sham or real rTMS
Drug: saline or naloxone pretreatment
saline or naloxone pretreatment
Placebo Comparator: Sham rTMS
Sham rTMS
 Procedure: sham or real rTMS
sham or real rTMS
Drug: saline or naloxone pretreatment
saline or naloxone pretreatment

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • history of depression or pain
  • history of seizures or epilepsy
  • metal implants in body
  • medications that lower seizure threshold
  • psychiatric medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643798

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29414
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Investigators
Study Director: Joseph J Taylor Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01643798     History of Changes
Other Study ID Numbers: 1F30DA033748-01, 1F30DA033748-01
Study First Received: June 22, 2012
Last Updated: July 16, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013