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

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04658485
• Other study ID #: N-20180085.p3
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: February 15, 2021

Study information

• Verified date: January 2021
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: February 15, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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).
• 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.

Locations

Country	Name	City	State
Denmark	Center for Neuroplasticity and Pain	Aalborg	Nordjylland

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University	Danish National Research Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Heat and Cold Pain Detection Thresholds	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.	Two assessments total: Once before the stimulation intervention (baseline) and once again five minutes after the stimulation (post intervention assessment).