The Effect of Transcranial Direct Current Stimulation of the Primary Motor and Somatosensory Cortex on Pain Thresholds.

NCT04658485 | Unknown

• 1 other identifier: N-20180085.p3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the modulatory effect of a novel tDCS configuration on the pain sensitivity in healthy subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change in pressure pain threshold

  A hand-held pressure algometer (Somedic, Hörby, Sweden) with a 1-cm2 probe was used to record the pressure pain threshold. The pressure is increased gradually at a rate of 30 kPa/s. The measurement is repeated three times on descending part of the medial musculus trapezius sinister and dexter respectively.

  Two assessments total: Once before the stimulation intervention (baseline assessment) and once again three minutes after the stimulation (post intervention assessment).

Secondary Outcomes (1)

• Change in Heat and Cold Pain Detection Thresholds

  Two assessments total: Once before the stimulation intervention (baseline) and once again five minutes after the stimulation (post intervention assessment).

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

Device: Active tDCS

Sham tDCS

PLACEBO COMPARATOR

Device: Sham tDCS

Interventions

Active tDCS DEVICE

Using the 2-channel neuro-stimulator Sooma tDCS equipment we provide 20 minutes of 2 mA anodal stimulation of the primary motor cortex (M1) with the cathode located over the right primary somatosensory cortex (S1).

Active tDCS

Sham tDCS DEVICE

Using the 2-channel neuro-stimulator Sooma tDCS equipment we provide a sham stimulation with the anode place over the primary motor cortex (M1) and cathode located over the right primary somatosensory cortex (S1). The sham stimulation consists of 30 seconds of stimulation ramping up to a maximum of 2 mA, then 19 minutes of the device providing no stimulation and then ramping down from 2 mA intensity to 0 in the last 30 seconds. This configuration is designed to mimic the sensory experience of active tDCS.

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• Age between 18-30 years
• Living in Denmark

You may not qualify if:

• Pregnancy
• Drug addiction defined as the use of cannabis, opioids or other drugs
• Current use of opioids, antipsychotics, benzodiazepines
• Previous or current neurological, musculoskeletal, rheumatic, malignant, inflammatory or mental illnesses
• Current or prior chronic pain conditions
• Lack of ability to cooperate

Sponsors & Collaborators

• Aalborg University: lead
• Danish National Research Foundation: collaborator

Study Sites (1)

Center for Neuroplasticity and Pain

Aalborg, North Denmark, 9000, Denmark

Location

Related Publications (1)

• Kold S, Kragh AJ, Graven-Nielsen CS, Elnegaard FS, Lund F, Vittrup IV, Cliff KL, Sivarooban R, Petrini L. Neuromodulation of somatosensory pain thresholds of the neck musculature using a novel transcranial direct current stimulation montage: a randomized double-blind, sham controlled study. Scand J Pain. 2022 Feb 7;22(3):622-630. doi: 10.1515/sjpain-2021-0187. Print 2022 Jul 26.

  PMID: 35130374 DERIVED

Study Officials

• Thomas Graven-Nielsen, Prof.

  Aalborg University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subjects are pseudo randomly allocated to either the active stimulation group or the sham stimulation group (placebo), ensuring equal weighting of male and female in the two groups. The care provider is handed the tDCS device which is preprogrammed by a third party either deliver the active or the sham stimulation based on the participation ID-number, effectively blinding the care provider. The outcome assessor and investigator is similarly blinded to the protocol administered to the participants.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD-fellow

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: December 8, 2020
• Study Start: November 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: February 15, 2021
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)