Clinical trial NCT04165876: HD-tDCS: Effects on the Somatosensory System
Official title: High Definition Transcranial Direct Current Stimulation: Effects on the Somatosensory System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Neuroplasticity
Brain Modulation
Somatosensory Function
Keywords: tDCS
HD-tDCS
Somatosensory function
QST
quantitative sensory testing
Non-invasive brain stimulation
NIBS
Transcranial Direct Current Stimulation
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Danish National Research Foundation
First posted: 2019-11-18
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Longitudinal, sham-controlled, parallel groups design.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in pressure pain threshold
timeFrame: 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.
Secondary outcomes:
measure: Change in tactile detection threshold
timeFrame: 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.
measure: Change in mechanical pain threshold
timeFrame: 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.
measure: Change in Thermal Sensory Detection
timeFrame: 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.
measure: Change in Thermal Pain Detection
timeFrame: 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.
measure: Change in conditioned pain modulation (CPM)
timeFrame: 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.
measure: Change in vibration detection threshold.
timeFrame: 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.
measure: Change in temporal summation of pain (TSP).
timeFrame: 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.
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Center for Neuroplasticity and Pain
state: Nordjylland
Study officials:
affiliation: Aalborg University
name: Thomas Graven-Nielsen, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kold S, Graven-Nielsen T. Effect of anodal high-definition transcranial direct current stimulation on the pain sensitivity in a healthy population: a double-blind, sham-controlled study. Pain. 2021 Jun 1;162(6):1659-1668. doi: 10.1097/j.pain.0000000000002187.