HD-tDCS: Effects on the Somatosensory System

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Primary Motor Cortex Stimulation

Dorsolateral Prefrontal Cortex Stimulation

Multimodal Stimulation (DLPFC+M1)

Sham stimulation

About this trial

This is an interventional basic science trial for Acute Pain focused on measuring tDCS, HD-tDCS, Somatosensory function, QST, quantitative sensory testing, Non-invasive brain stimulation, NIBS, Transcranial Direct Current Stimulation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Center for Neuroplasticity and Pain

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Arm Label

Primary motor cortex

Dorsolateral prefrontal cortex

Multi-modal stimulation (DLPFC+M1)

Sham-stimulation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in tactile detection threshold

Tactile threshold will be measured using an anaesthesiometer consisting of a set of Von Frey filaments. The filaments are made of nylon fibre of various diameters so as to provide a range of forces of up to 300 grams. The minimum force that the subject can detect will be identified. This will be assessed on flexor carpi radialis on the right hand arm.

Change in mechanical pain threshold

Mechanical pain threshold (MPT) will be measured using a set of weighted pinprick stimulators with a flat contact area of 0.25 mm diameter that exert forces between 8 and 512 mN. Threshold procedures will use a method of limits with up to five series of ascending and descending stimulus intensities. This will be assessed on flexor carpi radialis on the right hand arm.

Change in Thermal Sensory Detection

A 3×3 cm (9 cm2) contact thermode (Medoc Advanced Medical Systems, Israel) will be used to apply thermal stimulation. Each stimulus will be started at 32°C and thresholds of heat and cold sensory detection will be assessed by ascending or descending ramps in temperature to the cutoffs of 0-50 °C. This will be assessed on flexor carpi radialis on the right hand arm.

Change in Thermal Pain Detection

A 3×3 cm (9 cm2) contact thermode (Medoc Advanced Medical Systems, Israel) will be used to apply thermal stimulation. Each stimulus will be started at 32°C and thresholds of heat and cold pain detection will be assessed by ascending or descending ramps in temperature to the cutoffs of 0-50 °C. This will be assessed on flexor carpi radialis on the right hand arm.

Change in conditioned pain modulation (CPM)

A computer-controlled cuff pressure algometer (Nocitech, Denmark) with an air-filled tourniquet cuff (VBM, Germany) will be used to record cuff pressure-induced pain thresholds over the muscle bulk on the calfs. The pressure is increased gradually at a rate of 1 kPa/s to assess pain tolerance on a 0-10 VAS scale, where 0 is no pain at all and 10 is the worst pain imaginable. During CPM testing, the pain tolerance is first assessed on one leg marking the baseline. The pressure pain tolerance is then assessed on the same leg again, while the contralateral calf is applied a simultaneous painful pressure stimulus. The outcome of the CPM testing is the difference in pressure pain tolerance measured in kPA between the first and the second assessment. The larger the positive difference is between the baseline and the second assessment, the stronger CPM effect the subject has.

Change in vibration detection threshold.

Vibration detection threshold (VDT) will be determined with a Rydel-Seiffer tuning fork (64 Hz, 8/8 scale), which will be placed three times over a bony prominence of the distal part of the ulna on the right arm. Subjects are to indicate the disappearance of vibratory sensations.

Change in temporal summation of pain (TSP).

TSP will be applied using cuff pressure algometry. A total of 10 repeated mechanical pressure stimuli will be delivered at 0.5 Hz (1-s stimuli duration and 1-s interval between stimuli) to the test area. During the 10 repeated stimuli, subjects will continuously rate the pain intensity on a 10-cm continuous VAS. TSP is assessed on the calf of the right leg.

Full Information

NCT ID

NCT04165876

First Posted

September 11, 2019

Last Updated

June 11, 2020

Sponsor

Aalborg University

Collaborators

Danish National Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04165876

Brief Title

HD-tDCS: Effects on the Somatosensory System

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

December 18, 2018 (Actual)

Primary Completion Date

February 18, 2020 (Actual)

Study Completion Date

March 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aalborg University

Collaborators

Danish National Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Longitudinal, sham-controlled, parallel groups design.

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Primary motor cortex

Arm Type

Active Comparator

Arm Title

Dorsolateral prefrontal cortex

Arm Type

Active Comparator

Arm Title

Multi-modal stimulation (DLPFC+M1)

Arm Type

Active Comparator

Arm Title

Sham-stimulation

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

Primary Motor Cortex Stimulation

Intervention 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

Intervention Type

Device

Intervention Name(s)

Dorsolateral Prefrontal Cortex Stimulation

Intervention 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

Intervention Type

Device

Intervention Name(s)

Multimodal Stimulation (DLPFC+M1)

Intervention 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.

Intervention Type

Device

Intervention Name(s)

Sham stimulation

Intervention 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.

Primary Outcome Measure Information:

Title

Change in pressure pain threshold

Description

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.

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.

Secondary Outcome Measure Information:

Title

Change in tactile detection threshold

Description

Tactile threshold will be measured using an anaesthesiometer consisting of a set of Von Frey filaments. The filaments are made of nylon fibre of various diameters so as to provide a range of forces of up to 300 grams. The minimum force that the subject can detect will be identified. This will be assessed on flexor carpi radialis on the right hand arm.

Time Frame