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

• ClinicalTrials.gov Identifier: NCT04658485
• Recruitment Status: Active, not recruiting
• First Posted: December 8, 2020
• Last Update Posted: January 7, 2021
• Sponsor: Aalborg University
• Collaborator: Danish National Research Foundation
• Information provided by (Responsible Party): Sebastian Kold Sørensen, Aalborg University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Device: Active tDCS; Device: Sham tDCS	Not Applicable

Detailed Description:

The purpose of this study is to investigate the modulatory effect of a single session 20 min anodal primary motor cortex (M1) and cathodal primary somatosensory cortex (S1) transcranial direct current stimulation (tDCS) on the pain sensitivity on the descending part of musculus trapezius in healthy young adults.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Basic Science
• Official Title: The Modulatory Effect of Anodal Primary Motor Cortex and Cathodal Primary Somatosensory Cortex Transcranial Direct Current Stimulation on Pain Thresholds in the Neck Musculature.
• Actual Study Start Date: November 1, 2019
• Actual Primary Completion Date: December 1, 2020
• Estimated Study Completion Date: February 15, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Active tDCS	Device: Active tDCS; 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).
Placebo Comparator: Sham tDCS	Device: Sham tDCS; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in pressure pain threshold [ Time Frame: Two assessments total: Once before the stimulation intervention (baseline assessment) and once again three minutes after the stimulation (post intervention assessment). ]
   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.

Secondary Outcome Measures :

1. Change in Heat and Cold Pain Detection Thresholds [ Time Frame: Two assessments total: Once before the stimulation intervention (baseline) and once again five minutes after the stimulation (post intervention assessment). ]
   A 3×3 cm (9 cm2) contact thermode (Medoc Advanced Medical Systems, Israel) was used to apply thermal stimulation. Each stimulus will be started at 32°C and thresholds of heat and cold pain detection was assessed by ascending or descending ramps in temperature to the cutoffs of 0-50 °C. This will be assessed on the skin over the left side descending part of the medial musculus trapezius.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 30 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

Denmark

Center for Neuroplasticity and Pain

Aalborg, Nordjylland, Denmark, 9000

Sponsors and Collaborators

Aalborg University

Danish National Research Foundation

Investigators

• Study Director: Thomas Graven-Nielsen, Prof.; Aalborg University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. doi: 10.1515/sjpain-2021-0187. [Epub ahead of print]

• Responsible Party: Sebastian Kold Sørensen, PhD-fellow, Aalborg University
• ClinicalTrials.gov Identifier: NCT04658485
• Other Study ID Numbers: N-20180085.p3
• First Posted: December 8, 2020
• Last Update Posted: January 7, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No