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Modulation of an Experimental Prolonged Pain Model Using High Definition Transcranial Direct Current Stimulation

Primary Purpose

Pain, Muscle, Healthy

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Active HD-tDCS
Sham HD-tDCS
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain, Muscle

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 PainRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

Both groups will receive an injection with 5 μg (0.5 ml) Nerve Growth Factor (NGF) in the first dorsal interosseous muscle (FDI muscle) prior to the HD-tDCS intervention. This injection a pain model, that is intended to induce muscle soreness and hyperalgesia.

Both groups will receive an injection with 5 μg (0.5 ml) Nerve Growth Factor (NGF) in the first dorsal interosseous muscle (FDI muscle) prior to the HD-tDCS intervention. This injection a pain model, that is intended to induce muscle soreness and hyperalgesia.

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 20 kPa/s. The measurement is repeated three times on the first dorsal interosseous muscle.
Change in pressure pain tolerance.
A hand-held pressure algometer (Somedic, Hörby, Sweden) with a 1-cm2 probe will be used to record the pressure pain threshold at baseline. The pressure is increased gradually at a rate of 20 kPa/s. The measurement is repeated three times on the first dorsal interosseous muscle. The participant is asked to rate the pain on a numerical rating scale (NRS) from 0-10. 0 representing no pain at all, and 10 representing the worst pain imaginable.

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 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 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.
Change in electroencephalography response (EEG).
EEG will be recorded for four minutes prior to the HD-tDCS, during the HD-tDCS and four minutes immediately after the HD-tDCS. In the four minutes before and after HD-tDCS, the subject will have their eyes open for two minutes and their eyes closed for two minutes. The EEG data will be analyzed with a focus on the resting state. In particular the Alpha frequency brain waves are of interest, but exploratory analysis will be conducted on the Beta, Theta and Gamma frequency bands as well.

Full Information

First Posted
September 23, 2020
Last Updated
December 1, 2020
Sponsor
Aalborg University
Collaborators
Danish National Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04650048
Brief Title
Modulation of an Experimental Prolonged Pain Model Using High Definition Transcranial Direct Current Stimulation
Official Title
Modulation of an Experimental Prolonged Pain Model Using High Definition Transcranial Direct Current Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
April 29, 2021 (Anticipated)

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 double-blinded, parallel group randomized controlled trial is to investigate the effects of high definition transcranial direct current stimulation (HD-tDCS) on an experimental prolonged pain model in healthy subjects.
Detailed Description
The purpose of this double-blinded, parallel group randomized controlled trial is to investigate the effects of high definition transcranial direct current stimulation (HD-tDCS) on an experimental prolonged pain model in healthy subjects. Forty healthy participants are administered the compound Nerve Growth Factor (NGF) in the right first dorsal interosseous muscle (FDI), which produced prolonged muscle soreness and hyperalgesia. The forty participants are randomly allocated to either the control group receiving a Sham-tDCS paradigm, or the intervention group receiving three consecutive days of multimodal HD-tDCS targeting primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC) simultaneously. The somatosensory profile is assessed at baseline, before administration of NGF as well as prior and post each HD-tDCS session using standardised quantitative sensory testing. It is hypothesised that the active HD-tDCS will modulate the neurological changes induced by the experimental pain condition, which will alleviate the hyperalgesia and hypersensitivity.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The participants are pseudo-randomly allocated to either the intervention or the control group so as the two groups are equally weighted on gender. Using the build in double-blind software of the HD-tDCS device, the participant as well as investigator is blinded to the protocol that is administered.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Active Comparator
Arm Description
Both groups will receive an injection with 5 μg (0.5 ml) Nerve Growth Factor (NGF) in the first dorsal interosseous muscle (FDI muscle) prior to the HD-tDCS intervention. This injection a pain model, that is intended to induce muscle soreness and hyperalgesia.
Arm Title
Sham tDCS
Arm Type
Placebo Comparator
Arm Description
Both groups will receive an injection with 5 μg (0.5 ml) Nerve Growth Factor (NGF) in the first dorsal interosseous muscle (FDI muscle) prior to the HD-tDCS intervention. This injection a pain model, that is intended to induce muscle soreness and hyperalgesia.
Intervention Type
Device
Intervention Name(s)
Active HD-tDCS
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 HD-tDCS
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. This sham-configuration is intended to mimic the sensory experience of active HD-tDCS.
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 20 kPa/s. The measurement is repeated three times on the first dorsal interosseous muscle.
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.
Title
Change in pressure pain tolerance.
Description
A hand-held pressure algometer (Somedic, Hörby, Sweden) with a 1-cm2 probe will be used to record the pressure pain threshold at baseline. The pressure is increased gradually at a rate of 20 kPa/s. The measurement is repeated three times on the first dorsal interosseous muscle. The participant is asked to rate the pain on a numerical rating scale (NRS) from 0-10. 0 representing no pain at all, and 10 representing the worst pain imaginable.
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
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.
Title
Change in mechanical pain threshold
Description
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.
Time Frame
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.
Title
Change in conditioned pain modulation (CPM)
Description
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.
Time Frame
Three assessments over three days: Baseline is assessed before the stimulation at day one, and then again after the stimulation on the two subsequent days.
Title
Change in temporal summation of pain (TSP).
Description
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.
Time Frame
Three assessments over three days: Baseline is assessed before the stimulation at day one, and then again after the stimulation on the two subsequent days.
Title
Change in electroencephalography response (EEG).
Description
EEG will be recorded for four minutes prior to the HD-tDCS, during the HD-tDCS and four minutes immediately after the HD-tDCS. In the four minutes before and after HD-tDCS, the subject will have their eyes open for two minutes and their eyes closed for two minutes. The EEG data will be analyzed with a focus on the resting state. In particular the Alpha frequency brain waves are of interest, but exploratory analysis will be conducted on the Beta, Theta and Gamma frequency bands as well.
Time Frame
Three assessments over three days: The EEG will be recorded as a part of the HD-tDCS intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian Kold, MSc
Phone
+4522850345
Email
sks@hst.aau.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Graven-Nielsen, Prof.
Organizational Affiliation
Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Neuroplasticity and Pain
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Graven-Nielsen, Prof.
Phone
2216 049
Ext
+45
Email
tgn@hst.aau.dk

12. IPD Sharing Statement

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Modulation of an Experimental Prolonged Pain Model Using High Definition Transcranial Direct Current Stimulation

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