Effects of Non Invasive Brain Stimulation During Prolonged Experimental Pain

Not Applicable

Completed

• Conditions: Prolonged Experimental Pain; Pain
• Interventions: Device: Transcranial direct current stimulation (tDCS) of the resting state motor network

• Registration Number: NCT04246853
• Lead Sponsor: Aalborg University

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.

Detailed Description

There is evidence that chronic pain alters the frequency of alpha peaks. Specifically, recent studies showed a correlation between decreased frequency of alpha peaks and perceived pain. Furthermore, a correlation was found between high pain sensitivity and slower alpha oscillations during prolonged pain during 1 hour.

To date, the effects of prolonged experimental pain during 24 hours on brain oscillations has not been explored. Moreover, it is unknown whether non invasive brain stimulation (NIBS) through transcranial direct current stimulation (tDCS) can revert these pain-related feature.

It is hypothesized that prolonged pain during 24 hours will reduce the frequency of alpha peaks and tDCS of the resting state motor network will revert it to baseline values.

Furthermore, it is thought that decreased frequency of alpha peaks will be correlated with perceived pain intensity on Day 1 (before receiving the first tDCS session).

Study Timeline

• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-29
• Study Start: 2020-02-01
• Primary Completion: 2020-07-30
• Study Completion: 2020-07-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-19
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tDCS of the resting state motor network	Transcranial direct current stimulation (tDCS) of the resting state motor network	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.
Active tDCS of the resting state motor network	Transcranial direct current stimulation (tDCS) of the resting state motor network	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.

Primary Outcome Measures

Name	Time	Method
Frequency of alpha peaks	24 hours	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.
Perceived pain intensity	24 hours	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.

Secondary Outcome Measures

Name	Time	Method
Power of alpha oscillations	24 hours	Spectral analysis will be performed on alpha activity and it is expected that this outcome will be reduced by prolonged pain and tDCS of the resting state motor network will be able to normalize it.
Amplitude of alpha peak	24 hours	Similar to the primary outcome, the amplitude of the alpha peak will be extracted through EEG in the sensorimotor area. It is expected that prolonged pain will be able to reduce the amplitude of alpha peaks and tDCS will increase it back to baseline values or even higher.

Trial Locations

Locations (1)

Aalborg University; 🇩🇰 Aalborg, Nordylland, Denmark