Healthy
Conditions
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.
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.
Interventions
DEVICEActive 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).
DEVICESham 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.
Sponsors
Danish National Research Foundation
Aalborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pressure pain threshold | 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
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
Countries
Denmark
Outcome results
None listed