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| Name | Class |
|---|---|
| Danish National Research Foundation | OTHER |
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The purpose of this study is to investigate the modulatory effect of a novel tDCS configuration on the pain sensitivity in healthy subjects.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Active Comparator |
| |
| Sham tDCS | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Graven-Nielsen, Prof. | Aalborg University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Neuroplasticity and Pain | Aalborg | North Denmark | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35130374 | Derived | 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. |
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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.
| 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. |
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| Two assessments total: Once before the stimulation intervention (baseline) and once again five minutes after the stimulation (post intervention assessment). |