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

NCT03733015 | Completed DMC

• 1 other identifier: 54271916.8.0000.0068
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain Relief

Keywords

repetitive transcranial magnetic stimulation; dorsolateral prefrontal cortex; pain thresholds

Outcome Measures

Primary Outcomes (4)

• Pressure pain thresholds (PPT)

  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

  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)

  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)

  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.

Study Arms (2)

cTBS group

ACTIVE COMPARATOR

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

High frequenct rTMS group

ACTIVE COMPARATOR

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

Device: repetitive transcranial magnetic stimulation

Interventions

repetitive transcranial magnetic stimulation DEVICE

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

High frequenct rTMS group; cTBS group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers

You may not qualify if:

• Major medical conditions

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (2)

Enrico De Martino

Aalborg, North Denmark, 9000, Denmark

Location

Enrico De Martino

Aalborg, 9000, Denmark

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 7, 2018
• Study Start: October 10, 2018
• Primary Completion: December 15, 2018
• Study Completion: December 15, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)