CClinicalTrials.gg
Status unknownNCT04658485Updated Jan 7, 2021

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

An interventional study of Active tDCS and Sham tDCS in Healthy, sponsored by Aalborg University. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-07.

Sponsored by Aalborg University · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Nov 2019, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Healthy
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In context

Lead sponsor

Aalborg University is the lead sponsor of 178 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Active tDCS

    Device: Active tDCS

  • Placebo comparator
    Sham tDCS

    Device: Sham tDCS

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.

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What researchers measure

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.

    Time frame: 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

    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.

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

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Study locations

1 site
  • Center for Neuroplasticity and Pain
    Aalborg, Nordjylland 9000, Denmark
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References and documents

Publications

  • 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. PubMed 35130374 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04658485
Lead sponsor
Aalborg University
Collaborators
Danish National Research Foundation
Responsible party
Sebastian Kold Sørensen (PhD-fellow, Aalborg University) — Principal investigator
First posted
Dec 8, 2020
Start date
Nov 1, 2019
Primary completion
Dec 1, 2020
Completion
Feb 15, 2021 (estimated)
Last update
Jan 7, 2021

Study contacts

Thomas Graven-Nielsen, Prof.
study director · Aalborg University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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