Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain

March 2, 2018 updated by: Enrico De Martino, Aalborg University
The main purpose of the study is to assess the mechanisms of repeated sessions of repetitive trancranial magnetic stimulation (rTMS) applied on left dorsolateral prefrontal cortex on the development of pain in a prolonged muscle pain model.

Study Overview

Detailed Description

This study aims to investigate whether i) rTMS of left DLPFC will reduce the severity and duration of experimentally induced muscle pain when a 5-day course of treatment is given immediately following an initial nerve growth factor (NGF) injection; ii) the analgesic effects of left DLPFC rTMS will be related to an improved cognitive network function as assessed by electroencephalography (EEG).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nordjylland
      • Aalborg, Nordjylland, Denmark, 9000
        • Aalborg University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy men and women
  • Speak and understand English.

Exclusion Criteria:

  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Previous neurologic, musculoskeletal or mental illnesses
  • Lack of ability to cooperate
  • History of chronic pain or current acute pain
  • Previous experience with rTMS
  • Contraindications to rTMS application (history of epilepsy, metal in the head or jaw etc.).
  • Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real treatment group

Transcranial magnetic stimulation (TMS) is used to stimulate small regions of the brain. During a TMS procedure, a magnetic field generator, or "coil", is placed near the head of the person receiving the treatment. The coil produces small electric currents in the region of the brain just under the coil via electromagnetic induction.

The protocol used in this research includes 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses.

Repetitive trancranial magnetic stimulation is applied on the dorsolateral prefrontal cortex. The protocol consists on 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses.
Sham Comparator: Sham treatment group
Sham coil is used to mimic the clicking sound of the TMS coil and skin stimulation
A sham coil is used to mimic the clicking sound of the trancranial magnetic coil and skin stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief
Time Frame: Change from baseline at 2 weeks
Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)
Change from baseline at 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle soreness
Time Frame: Change from baseline at 2 weeks
7-point Likert scale; 0 = 'a complete absence of soreness', 1 = 'a light soreness in the muscle felt only when touched/vague ache', 2 = 'a moderate soreness felt only when touched/a slight persistent ache', '3 = 'a light muscle soreness when lifting or carrying objects', 4 = 'a light muscle soreness, stiffness or weakness when moving the wrist without gripping an object', 5 = 'a moderate muscle soreness, stiffness or weakness when moving the wrist', 6 = 'a severe muscle soreness, stiffness or weakness that limits the ability to move'
Change from baseline at 2 weeks
Patient-rated Tennis Elbow Evaluation
Time Frame: Change from baseline at 2 weeks
The Patient-rated Tennis Elbow Evaluation will be used to assess average pain and disability of the injected arm
Change from baseline at 2 weeks
Pressure pain thresholds
Time Frame: Change from baseline at 2 weeks
Pressure applied to the surface of the skin using a handheld algometer.
Change from baseline at 2 weeks
Attention network test
Time Frame: Change from baseline at 2 weeks
This task assesses cognitive function in 3 domains: alerting, orienting, and executive function
Change from baseline at 2 weeks
Cuff pressure algometry
Time Frame: Change from baseline at 2 weeks
The experimental setup consists of a tourniquet cuff, a computer-controlled air compressor and an electronic visual analog scale VAS (Aalborg University, Denmark). The cuff is connected to the compressor and wrapped around the leg. The pain intensity is recorded with the electronic VAS and sampled at 10 Hz. The "0 cm" and "10 cm" extremes on the VAS are defined as "no pain" and as "maximal pain", respectively. The compression rate of the cuff is programmed on and controlled by a computer.
Change from baseline at 2 weeks
EEG recordings
Time Frame: Change from baseline at 1 weeks
we will record brain activity in the following conditions: eyes closed rest, performance of a computer-based cognitive task (ANT).
Change from baseline at 1 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Enrico De Martino, MD, Aalborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

November 30, 2017

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

August 24, 2017

First Submitted That Met QC Criteria

August 25, 2017

First Posted (Actual)

August 28, 2017

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 2, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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