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Effects of Non Invasive Brain Stimulation During Prolonged Experimental Pain

NCT ID: NCT04246853

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2020-07-30

Brief Summary

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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

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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).

Conditions

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Pain Prolonged Experimental Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The current studies have a randomized, parallel, sham-controlled and double-blinded design.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Double-blinding is performed by a third-party which is not part of the research group

Study Groups

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Active 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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Sham 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.

Group Type SHAM_COMPARATOR

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

Intervention Type 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.

Interventions

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

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aalborg University

OTHER

Sponsor Role lead

Responsible Party

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Luisina Gregoret

Biomedical engineer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aalborg University

Aalborg, Nordylland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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N-20180092

Identifier Type: -

Identifier Source: org_study_id