Daily Sessions of rTMS to the Left DLPFC Modulate the Pain Thresholds and CPM

December 15, 2018 updated by: Enrico De Martino, Aalborg University

Can Daily Sessions of rTMS to the Left DLPFC Boost Diffuse Noxious Inhibitory Control and Pain Thresholds in Healthy Subjects

The main purpose of the study is to assess whether repeated sessions of repetitive trancranial magnetic stimulation (rTMS) applied on left dorsolateral prefrontal cortex main boost the pain thresholds.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pain is the largest health-related burden on society and, despite many decades of pain research, there are still few effective treatments. Since pain experience is a construct of the central nervous system (CNS), chronic pain has been recently thought to be a CNS disorder.

Repetitive transcranial magnetic stimulation (rTMS) is a safe, non-invasive technique for cerebral cortex stimulation and the clinical applications of which have expanded considerably in recent years. Recent studies have been shown that 'classical' rTMS to different cortical areas temporary reduce chronic and acute pain, suggesting that rTMS may ´have some clinical application in future management of chronic pain. However, new rTMS paradigms involving theta burst stimulation (TBS) have recently been described with the major clinical advantage to be much shorter than 'classical' rTMS. The investigators hypothesize that cTBS would yield analgesic effects similar to or, possibly, even stronger than those produced by 'classical' rTMS. The investigators will carry out a sham-controlled, randomized, double-blind, crossover study in healthy volunteers, to compare the analgesic effects of two rTMS protocols over dorsolateral prefrontal cortex: classical high-frequency rTMS (10 Hz), and TBS. As rTMS-induced analgesia may be dependent on changes in pain modulatory systems, the investigators will analyze the effects of the stimulation on conditioned pain modulation (CPM). More specifically, the investigators will compare the effects of multiple sessions of rTMS on the inhibition of a test experimental stimulus induced by heterotopic noxious stimuli, to assess possible changes in diffuse noxious inhibitory controls.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Denmark
      • Aalborg, Denmark, 9000
        • Enrico De Martino
    • Nordjylland
      • Aalborg, Nordjylland, Denmark, 9000
        • Enrico De Martino

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Major medical conditions

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: cTBS 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. TBS refers to a rTMS protocol where pulses are applied in bursts of three, delivered at a frequency of 50 Hz and an inter-burst interval of 200 ms (5 Hz).
Device: repetitive transcranial magnetic stimulation
Repetitive transcranial Magnetic Stimulation (rTMS) can be used to temporary modify the brain activity.
Active Comparator: High frequenct rTMS group
High frequency refers to a rTMS protocol where pulses are applied in at 10Hz frequency
Device: repetitive transcranial magnetic stimulation
Repetitive transcranial Magnetic Stimulation (rTMS) can be used to temporary modify the brain activity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pressure pain thresholds (PPT)
Time Frame: The study comprises two interventions of four experimental sessions on consecutive days (Day-1 to Day-4). Changes from Day-1 at Day-4 will be investigated.
Pressure will be applied at a rate of 30 kPa/s perpendicularly to the surface of the skin using a handheld algometer (1-cm2 probe; Somedic, Hörby, Sweden). Three readings at the pressure pain threshold (PPT) will be made at 1-minute intervals, at four sites; i) right elbow, ii) left elbow, iii) right leg and iv) left leg. The data will be reported in kPa.
The study comprises two interventions of four experimental sessions on consecutive days (Day-1 to Day-4). Changes from Day-1 at Day-4 will be investigated.
Cold pain thresholds, heat pain thresholds and supra-thresholds painful stimuli
Time Frame: The study comprises two interventions of four experimental sessions on consecutive days (Day-1 to Day-4). Changes from Day-1 at Day-4 will be investigated.
The temperature of the thermode is slowly decreased or increased to the maximum tolerable levels. The participant will click a button as soon as the tolerable level has been reached, which will bring the temperature back to baseline 32 degrees Celsius. Thresholds are determined by raising or dropping the temperature slowly from baseline skin temperature until the participant reports feeling of pain. The experimenter will then determine the temperature that is consistently rated as moderately painful by applying a temperature above the threshold level and asking the participant to rate the pain from 0 (no pain) to 10 (most intense pain imaginable).
The study comprises two interventions of four experimental sessions on consecutive days (Day-1 to Day-4). Changes from Day-1 at Day-4 will be investigated.
Condition pain modulation (supra-thresholds painful stimuli ): visual analogue scale (VAS: 0-100mm)
Time Frame: The study comprises two interventions of four experimental sessions on consecutive days (Day-1 to Day-4). Changes from Day-1 at Day-4 will be investigated.
First, the volunteers will immerse the left hand in a bucket with water and ice at 4° C for around 45-60 seconds to reach a VAS pain of 60-70/100mm. Immediately after, supra-thresholds painful stimuli over the right leg will be repeated in a randomized order. The supra-thresholds painful stimuli will be reported in a VAS scale (from 0 to 10).
The study comprises two interventions of four experimental sessions on consecutive days (Day-1 to Day-4). Changes from Day-1 at Day-4 will be investigated.
Condition pain modulation (pressure pain thresholds): visual analogue scale (VAS: 0-100mm)
Time Frame: The study comprises two interventions of four experimental sessions on consecutive days (Day-1 to Day-4). Changes from Day-1 at Day-4 will be investigated.
First, the volunteers will immerse the left hand in a bucket with water and ice at 4° C for around 45-60 seconds to reach a VAS pain of 60-70/100mm. Immediately after, pressure pain thresholds over the right leg will be repeated. The pressure pain thresholds will be reported in kPa.
The study comprises two interventions of four experimental sessions on consecutive days (Day-1 to Day-4). Changes from Day-1 at Day-4 will be investigated.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 54271916.8.0000.0068

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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