Effects of Non Invasive Brain Stimulation During Prolonged Experimental Pain

NCT04246853 | Completed

• 1 other identifier: N-20180092
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Non invasive brain stimulation (NIBS) of the primary motor cortex (M1) through transcranial direct current stimulation (tDCS) has been widely investigated in research and clinical settings in order to modulate brain plasticity and improve clinical pain. Interestingly, newly developed paradigms i.e. tDCS of the resting state motor network have proved higher modulatory effects in terms of corticospinal excitability when compared to traditional M1 tDCS. However, little is known about the effects of tDCS on the frequency changes of alpha oscillations (alpha peaks). Interestingly, previous studies show a correlation between reduced frequencies of alpha peaks during 1-hour experimental pain in comparison to baseline. The present study aims to investigate the effects of tDCS of the resting state motor network on the frequency and power of alpha peaks during prolonged experimental pain during 24 hours.

Conditions

Pain; Prolonged Experimental Pain

Outcome Measures

Primary Outcomes (2)

• Frequency of alpha peaks

  The frequency of alpha peaks will be extracted through electroencephalography (EEG) in the sensorimotor areas (Central-Parietal) of the brain. It is hypothesized that the frequency of alpha peaks will be reduced due to prolonged pain. It is expected that tDCS of the resting state motor network will revert the frequency to baseline values or even higher.

  24 hours

• Perceived pain intensity

  Perceived pain intensity will be rated in a 0-10 Numerical rating scale (NRS): 0 no pain and 10 worst pain imaginable. Prolonged pain will increase perceived pain intensity. It is expected that active tDCS will not be able to reduce perceived pain intensity in comparison to sham tDCS.

  24 hours

Secondary Outcomes (2)

• Amplitude of alpha peak

  24 hours

• Power of alpha oscillations

  24 hours

Other Outcomes (1)

• Amplitude of Mu-oscillations during motor imagery

  24 hours

Study Arms (2)

Active tDCS of the resting state motor network

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 (tDCS) of the resting state motor network

Sham tDCS of the resting state motor network

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 (tDCS) of the resting state motor network

Interventions

Transcranial direct current stimulation (tDCS) of the resting state motor network DEVICE

Transcranial direct current stimulation (tDCS) 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 tDCS of the resting state motor network; Sham tDCS of the resting state motor network

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
• Current use of medications that may affect the trial
• Contraindications to rTMS application (history of epilepsy, metal implants in head or jaw, etc.)
• Failure to pass the questionnaire for tDCS

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Aalborg University

Aalborg, Nordylland, 9000, Denmark

Location

MeSH Terms

Conditions

Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinding is performed by a third-party which is not part of the research group
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biomedical engineer

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

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: February 1, 2020
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

DK (1)