Modulation of an Experimental Prolonged Pain Model Using High Definition Transcranial Direct Current Stimulation
NCT ID: NCT04650048
Last Updated: 2020-12-02
Study Results
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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UNKNOWN
NA
40 participants
INTERVENTIONAL
2020-08-01
2021-04-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
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.
Study Groups
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Active tDCS
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.
Active HD-tDCS
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 tDCS
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.
Sham HD-tDCS
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.
Interventions
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Active HD-tDCS
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 HD-tDCS
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.
Eligibility Criteria
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Inclusion Criteria
* Able to speak, read and understand English or Danish.
Exclusion Criteria
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Danish National Research Foundation
OTHER
Aalborg University
OTHER
Responsible Party
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Sebastian Kold Sørensen
Ph.D. fellow
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
Countries
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Central Contacts
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Facility Contacts
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Thomas Graven-Nielsen, Prof.
Role: primary
Other Identifiers
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N-20180085.p2
Identifier Type: -
Identifier Source: org_study_id