HD-tDCS: Effects on the Somatosensory System

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

Sponsors

Lead Sponsor: Aalborg University

Collaborator: Danish National Research Foundation

Source Aalborg University
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.

Overall Status Completed
Start Date December 18, 2018
Completion Date March 18, 2020
Primary Completion Date February 18, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in pressure pain threshold 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 Outcome
Measure Time Frame
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.
Enrollment 81
Condition
Intervention

Intervention Type: Device

Intervention Name: Primary Motor Cortex Stimulation

Description: Using the Starstim 32, HD-tDCS equipment we provide 20 minutes of 2 mA anodal stimulation of primary motor cortex (M1) using a ring-cathode configuration

Arm Group Label: Primary motor cortex

Intervention Type: Device

Intervention Name: Dorsolateral Prefrontal Cortex Stimulation

Description: Using the Starstim 32, HD-tDCS equipment we provide 20 minutes of 2 mA anodal stimulation of dorsolateral prefrontal cortex (DLPFC) using a ring-cathode configuration

Arm Group Label: Dorsolateral prefrontal cortex

Intervention Type: Device

Intervention Name: Multimodal Stimulation (DLPFC+M1)

Description: Using the Starstim 32, HD-tDCS equipment we provide 20 minutes of 2 mA anodal multimodal stimulation of dorsolateral prefrontal cortex (DLPFC) and primary motor cortex simultaneously using ring-cathode configurations around the two anodes.

Arm Group Label: Multi-modal stimulation (DLPFC+M1)

Intervention Type: Device

Intervention Name: Sham stimulation

Description: Using the Starstim 32, HD-tDCS equipment we provide sham stimulation with 30 seconds of ramping up to 2 mA intensity, then turning off for 19 minutes and then ramping down from 2 mA intensity to 0 in the last 30 seconds.

Arm Group Label: Sham-stimulation

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Thomas Graven-Nielsen, Prof. Principal Investigator Aalborg University
Location
Facility: Center for Neuroplasticity and Pain
Location Countries

Denmark

Verification Date

June 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Aalborg University

Investigator Full Name: Sebastian Kold Sørensen

Investigator Title: PhD-fellow

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Primary motor cortex

Type: Active Comparator

Label: Dorsolateral prefrontal cortex

Type: Active Comparator

Label: Multi-modal stimulation (DLPFC+M1)

Type: Active Comparator

Label: Sham-stimulation

Type: Sham Comparator

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Longitudinal, sham-controlled, parallel groups design.

Primary Purpose: Basic Science

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: The stimulation protocol is blinded and randomized using the software's "double-blinding" function. The subjects are randomly assigned to one of four groups receiving the corresponding stimulation protocol. One of which is a sham-stimulation (placebo), that imitates the experience of real stimulation.

Source: ClinicalTrials.gov