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

NCT ID: NCT03733015

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-10

Study Completion Date

2018-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain Relief

Keywords

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repetitive transcranial magnetic stimulation dorsolateral prefrontal cortex pain thresholds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

repetitive transcranial magnetic stimulation

Intervention Type DEVICE

Repetitive transcranial Magnetic Stimulation (rTMS) can be used to temporary modify the brain activity.

High frequenct rTMS group

High frequency refers to a rTMS protocol where pulses are applied in at 10Hz frequency

Group Type ACTIVE_COMPARATOR

repetitive transcranial magnetic stimulation

Intervention Type DEVICE

Repetitive transcranial Magnetic Stimulation (rTMS) can be used to temporary modify the brain activity.

Interventions

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repetitive transcranial magnetic stimulation

Repetitive transcranial Magnetic Stimulation (rTMS) can be used to temporary modify the brain activity.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers

Exclusion Criteria

* Major medical conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aalborg University

OTHER

Sponsor Role lead

Responsible Party

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Enrico De Martino

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Enrico De Martino

Aalborg, North Denmark, Denmark

Site Status

Enrico De Martino

Aalborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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54271916.8.0000.0068

Identifier Type: -

Identifier Source: org_study_id