HD-tDCS: Effects on the Somatosensory System

NCT04165876 | Completed

• 1 other identifier: N-20180085.v1
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in pressure pain threshold

  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.

  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 (7)

• 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.

Study Arms (4)

Primary motor cortex

ACTIVE COMPARATOR

Device: Primary Motor Cortex Stimulation

Dorsolateral prefrontal cortex

ACTIVE COMPARATOR

Device: Dorsolateral Prefrontal Cortex Stimulation

Multi-modal stimulation (DLPFC+M1)

ACTIVE COMPARATOR

Device: Multimodal Stimulation (DLPFC+M1)

Sham-stimulation

SHAM COMPARATOR

Device: Sham stimulation

Interventions

Primary Motor Cortex Stimulation DEVICE

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

Primary motor cortex

Dorsolateral Prefrontal Cortex Stimulation DEVICE

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

Dorsolateral prefrontal cortex

Multimodal Stimulation (DLPFC+M1) DEVICE

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.

Multi-modal stimulation (DLPFC+M1)

Sham stimulation DEVICE

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.

Sham-stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead
• Danish National Research Foundation: collaborator

Study Sites (1)

Center for Neuroplasticity and Pain

Aalborg, North Denmark, 9000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 33449508 DERIVED

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Graven-Nielsen, Prof.

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD-fellow

Model Details: Longitudinal, sham-controlled, parallel groups design.

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: November 18, 2019
• Study Start: December 18, 2018
• Primary Completion: February 18, 2020
• Study Completion: March 18, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)