Clinical trial NCT04165980: Modulatory Effects of Multichannel tDCS During Prolonged Experimental Pain
Official title: Effects of Non-invasive Brain Stimulation Methods in Experimentally Induced Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolonged Pain
Neuroplasticity
Brain Modulation
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 38
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The current studies have a randomized, parallel, sham-controlled and double-blinded design.
Primary purpose: BASIC_SCIENCE

Brief summary: Corticomotor excitability, pain sensitivity, descending pain control and somatosensory evoked potentials (SEPs) is often altered in acute and chronic pain.

Topical capsaicin generates stable, long-lasting hyperalgesia and ongoing tonic pain in healthy participants, which significantly inhibits corticomotor excitability in the primary motor cortex (M1).

Recent studies (by Fischer et al 2017) indicated that multifocal Transcranial Direct Current Stimulation (tDCS) administered to brain regions linked to the resting state motor network (network-tDCS) could enhance corticomotor excitability in healthy participants compared to single site M1-tDCS.

It remains unknown whether network-tDCS has also the potential to modulate the inhibitory effects on motor cortex excitability, pain sensitivity, descending pain control and SEPs associated with prolonged pain

Detailed description: To date, pain modulation to M1 rs-network tDCS during 8% capsaicin induced pain has not been assessed (Mylius, Borckardt and Lefaucheur, 2012). Further, it is unknown how multichannel tDCS acts on tonic cutaneous pain for approximately 24 hours.

The main objective of these projects are to study and characterize quantitatively the effects of multichannel tDCS in the development of prolonged pain.

It is hypothesized that multichannel tDCS of left M1 resting-state network will reduce the severity of experimentally prolonged pain over the m. first dorsal interosseous (FDI), will increase descending pain control, might possibly increase pain thresholds and simultaneously will modulate the peak-to-peak amplitude of SEPs to electrical painful stimulation. Further, it is hypothesized that descending pain modulation of M1 tDCS will be related to interference with the suppression of cortical excitability

Eligibility criteria: Inclusion Criteria:

-Right-handed healthy men and women in the age 21-50 years who speak and understand English

Exclusion Criteria:

* Lack of ability to cooperate
* History of chronic pain or current acute pain
* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Present and previous neurologic, musculoskeletal or mental illnesses
* Chili allergies (subproject 1 and 2)
* Current use of medications that may affect the trial
* Previous experience with rTMS and tDCS
* Contraindications to rTMS application (history of epilepsy, metal implants in head or jaw, etc.)
* Failure to pass the questionnaire for tDCS
* Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen) (Rossi et al., 2001)

Primary outcomes:
measure: Corticomotor excitability
timeFrame: 24 hours
Secondary outcomes:
measure: Conditioned pain modulation effect
timeFrame: 24 hours
measure: Warm detection thresholds (sensitivity measure)
timeFrame: 24 hours
measure: Heat pain thresholds (pain sensitivity measure)
timeFrame: 24 hours
measure: Mechanical pain thresholds (pain sensitivity measure)
timeFrame: 24 hours
measure: Cuff pressure pain sensitivity
timeFrame: 24 hours
measure: Amplitude of SEPs to electrical painful stimulation
timeFrame: 24 hours
measure: Latency of SEPs to electrical painful stimulation
timeFrame: 24 hours
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
state: Nordylland
Study officials:
affiliation: Aalborg University
name: Thomas Graven-Nielsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: