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

Aalborg University

Status: Unknown

Conditions: Pain, Muscle; Healthy

Treatments: Device: Active HD-tDCS; Device: Sham HD-tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT04650048

N-20180085.p2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Active tDCS

Active Comparator group

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.

Treatment:

Device: Active HD-tDCS

Sham tDCS

Placebo Comparator group

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.

Treatment:

Device: Sham HD-tDCS