HD-tDCS: Effects on the Somatosensory System

NCT ID: NCT04165876

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-18

Study Completion Date

2020-03-18

Brief Summary

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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

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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.

Conditions

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Acute Pain Neuroplasticity Brain Modulation Somatosensory Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Longitudinal, sham-controlled, parallel groups design.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Primary motor cortex

Group Type ACTIVE_COMPARATOR

Primary Motor Cortex Stimulation

Intervention Type 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

Dorsolateral prefrontal cortex

Group Type ACTIVE_COMPARATOR

Dorsolateral Prefrontal Cortex Stimulation

Intervention Type 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

Multi-modal stimulation (DLPFC+M1)

Group Type ACTIVE_COMPARATOR

Multimodal Stimulation (DLPFC+M1)

Intervention Type 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.

Sham-stimulation

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type 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.

Interventions

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Primary Motor Cortex Stimulation

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

Intervention Type DEVICE

Dorsolateral Prefrontal Cortex Stimulation

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

Intervention Type DEVICE

Multimodal Stimulation (DLPFC+M1)

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.

Intervention Type DEVICE

Sham stimulation

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danish National Research Foundation

OTHER

Sponsor Role collaborator

Aalborg University

OTHER

Sponsor Role lead

Responsible Party

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Sebastian Kold Sørensen

PhD-fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Graven-Nielsen, Prof.

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Locations

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Center for Neuroplasticity and Pain

Aalborg, North Denmark, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 33449508 (View on PubMed)

Other Identifiers

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N-20180085.v1

Identifier Type: -

Identifier Source: org_study_id

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