Modulatory Effects of Multichannel tDCS During Prolonged Experimental Pain

NCT04165980 | Completed DMC

• 1 other identifier: VN-20180092
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Conditions

Prolonged Pain; Neuroplasticity; Brain Modulation

Outcome Measures

Primary Outcomes (1)

• Corticomotor excitability

  Corticomotor excitability is expressed as the peak-to-peak amplitude of motor evoked potentials to single-pulse transcranial magnetic stimulation. It is expected that network-tDCS will reduce corticomotor inhibition induced by tonic pain during 24 hours.

  24 hours

Secondary Outcomes (7)

• Conditioned pain modulation effect

  24 hours

• Warm detection thresholds (sensitivity measure)

  24 hours

• Heat pain thresholds (pain sensitivity measure)

  24 hours

• Mechanical pain thresholds (pain sensitivity measure)

  24 hours

• Cuff pressure pain sensitivity

  24 hours

Study Arms (2)

Sham transcranial direct current stimulation (sham tDCS)

SHAM COMPARATOR

This study has a parallel design and 2 groups: Active tDCS and Sham tDCS. Sham tDCS applies a standard sham protocol consisting of ramping up and down during 30 seconds at the beginning and at the end of each tDCS session. Each tDCS session lasts 20 minutes and applies a total current of 4mA.

Device: transcranial direct current stimulation

Active transcranial direct current stimulation (activetDCS)

ACTIVE COMPARATOR

The active comparator is the Active tDCS group. The active tDCS will target the resting-state motor network and will apply a distributed direct current during the whole session. (The TIME during the direct current is applied is the only difference with Sham tDCS) Each tDCS session lasts 20 minutes and applies a total current of 4mA.

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

Transcranial direct current stimulation delivers a low intensity current of up to 4 mA per session through small and circular shaped electrodes applied over the scalp. This induces a weak but focal electrical field that may modify the excitability of the underlying cortical target in a polarity and activity dependent fashion.

Active transcranial direct current stimulation (activetDCS); Sham transcranial direct current stimulation (sham tDCS)

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Aalborg University

Aalborg, Nordylland, 9000, Denmark

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Thomas Graven-Nielsen, PhD

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Fellow

Model Details: The current studies have a randomized, parallel, sham-controlled and double-blinded design.

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 18, 2019
• Study Start: March 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: February 28, 2020
• Last Updated: June 24, 2020

Record last verified: 2020-06

Locations

DK (1)