Clinical trial NCT03733015: Daily Sessions of rTMS to the Left DLPFC Modulate the Pain Thresholds and CPM
Official title: Can Daily Sessions of rTMS to the Left DLPFC Boost Diffuse Noxious Inhibitory Control and Pain Thresholds in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Relief
Keywords: repetitive transcranial magnetic stimulation
dorsolateral prefrontal cortex
pain thresholds
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Major medical conditions

Primary outcomes:
measure: Pressure pain thresholds (PPT)
timeFrame: 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.
measure: Cold pain thresholds, heat pain thresholds and supra-thresholds painful stimuli
timeFrame: 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.
measure: Condition pain modulation (supra-thresholds painful stimuli ): visual analogue scale (VAS: 0-100mm)
timeFrame: 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.
measure: Condition pain modulation (pressure pain thresholds): visual analogue scale (VAS: 0-100mm)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Enrico De Martino
state: Nordjylland
city: Aalborg
country: Denmark
facility: Enrico De Martino
Study officials:
References: