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Clinical Trials/NCT04165876
NCT04165876
Completed
Not Applicable

High Definition Transcranial Direct Current Stimulation: Effects on the Somatosensory System

Aalborg University1 site in 1 country81 target enrollmentDecember 18, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Pain
Sponsor
Aalborg University
Enrollment
81
Locations
1
Primary Endpoint
Change in pressure pain threshold
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to investigate the efficacy of high definition tDCS on different cortical targets in modulating the nociceptive system in the healthy subjects.

Detailed Description

The investigators aim to investigate the efficacy of different HD-tDCS electrode configurations on modulating the somatosensory/nociceptive system. This is done to investigate the hypothesis, that different stimulation protocols can be used to modulate the somatosensory and nociceptive system, as shown in the previous studies, but that it is necessary to uncover the most efficient way to do so. The study uses a double-blinded, sham-controlled, longitudinal design, where quantitative sensory testing will be used to assess the somatosensory function of the participants before and after a receiving a specific configuration of HD-tDCS on three consecutive days.

Registry
clinicaltrials.gov
Start Date
December 18, 2018
End Date
March 18, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aalborg University
Responsible Party
Principal Investigator
Principal Investigator

Sebastian Kold Sørensen

PhD-fellow

Aalborg University

Eligibility Criteria

Inclusion Criteria

  • Healthy men and women.
  • Able to speak, read and understand English or Danish.

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

Outcomes

Primary Outcomes

Change in pressure pain threshold

Time Frame: Six assessments over three days: Baseline is assessed before any intervention at day one, and then the pain thresholds are assessed before and after each intervention on the subsequent two days.

A hand-held pressure algometer (Somedic, Hörby, Sweden) with a 1-cm2 probe will be 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 on flexor carpi radialis.

Secondary Outcomes

  • Change in tactile detection threshold(Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.)
  • Change in mechanical pain threshold(Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.)
  • Change in Thermal Sensory Detection(Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.)
  • Change in Thermal Pain Detection(Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.)
  • Change in conditioned pain modulation (CPM)(Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.)
  • Change in vibration detection threshold.(Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.)
  • Change in temporal summation of pain (TSP).(Six assessments over three days: Baseline is assessed before any intervention at day one, and then the sensory thresholds are assessed before and after each intervention on the subsequent two days.)

Study Sites (1)

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