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Effects of Non Invasive Brain Stimulation During Prolonged Experimental Pain

A

Aalborg University

Status

Completed

Conditions

Prolonged Experimental Pain
Pain

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04246853
N-20180092

Details and patient eligibility

About

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.

Full 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).

Enrollment

44 patients

Sex

All

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

44 participants in 2 patient groups

Active tDCS of the resting state motor network
Active Comparator group
Description:
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.
Treatment:
Device: Transcranial direct current stimulation (tDCS) of the resting state motor network
Sham tDCS of the resting state motor network
Sham Comparator group
Description:
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.
Treatment:
Device: Transcranial direct current stimulation (tDCS) of the resting state motor network

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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