Clinical trial NCT04650048: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Muscle
Healthy
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Danish National Research Foundation
First posted: 2020-12-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in pressure pain threshold.
timeFrame: 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.
measure: Change in pressure pain tolerance.
timeFrame: 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:
measure: Change in tactile detection threshold
timeFrame: 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.
measure: Change in mechanical pain threshold
timeFrame: 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.
measure: Change in conditioned pain modulation (CPM)
timeFrame: 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.
measure: Change in temporal summation of pain (TSP).
timeFrame: 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.
measure: Change in electroencephalography response (EEG).
timeFrame: Three assessments over three days: The EEG will be recorded as a part of the HD-tDCS intervention.
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Center for Neuroplasticity and Pain
state: Nordjylland
Study officials:
affiliation: Aalborg University
name: Thomas Graven-Nielsen, Prof.
role: PRINCIPAL_INVESTIGATOR
References: