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Effects of Cerebral and Peripheral Electrical Stimulation on Conditioned Pain Modulation in Healthy Subjects.

NCT ID: NCT03752502

Last Updated: 2023-11-28

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

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2021-11-27

Brief Summary

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The Neuromatrix pain model and new findings on pain chronification process point to a greater efficacy of treatments that address central and peripheral rather than only peripheral structures. Both cerebral and peripheral electrical stimulations can modulate brain areas involved in pain processing. However, their effects on pain modulation systems and clinical outcomes are lacking.

This study aims to investigate the efficacy of transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (PES) alone as well tDCS combined with PES on pressure pain threshold and conditioned pain modulation in healthy subjects.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Cerebral stimulation

Active transcranial direct current stimulation

tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).

Group Type EXPERIMENTAL

Transcranial direct current stimulation (tDCS)

Intervention Type PROCEDURE

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various chronic pain conditions. However, as a monotherapy for pain relief, this therapy still has controversial results.

Combined stimulation

Active transcranial direct current stimulation combined with active peripheral electrical stimulation (PES)

tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).

PES: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level.

Group Type EXPERIMENTAL

Transcranial direct current stimulation (tDCS)

Intervention Type PROCEDURE

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various chronic pain conditions. However, as a monotherapy for pain relief, this therapy still has controversial results.

Peripheral electrical stimulation (PES)

Intervention Type PROCEDURE

Peripheral electrical stimulation (PES) activates a complex neural network involving a series of neurotransmitters and receptors capable of promoting segmental and extrasegmental analgesia.

Sham cerebral stimulation

Sham transcranial direct current stimulation combined with active peripheral electrical stimulation (PES)

tDCS: 20 minutes (30s ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type PROCEDURE

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various chronic pain conditions. However, as a monotherapy for pain relief, this therapy still has controversial results.

Peripheral stimulation

Active peripheral electrical stimulation (PES).

PES: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level.

Group Type EXPERIMENTAL

Peripheral electrical stimulation (PES)

Intervention Type PROCEDURE

Peripheral electrical stimulation (PES) activates a complex neural network involving a series of neurotransmitters and receptors capable of promoting segmental and extrasegmental analgesia.

Sham tDCS

Intervention Type PROCEDURE

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various chronic pain conditions. However, as a monotherapy for pain relief, this therapy still has controversial results.

Interventions

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Transcranial direct current stimulation (tDCS)

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various chronic pain conditions. However, as a monotherapy for pain relief, this therapy still has controversial results.

Intervention Type PROCEDURE

Peripheral electrical stimulation (PES)

Peripheral electrical stimulation (PES) activates a complex neural network involving a series of neurotransmitters and receptors capable of promoting segmental and extrasegmental analgesia.

Intervention Type PROCEDURE

Sham tDCS

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various chronic pain conditions. However, as a monotherapy for pain relief, this therapy still has controversial results.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Healthy subjects without medical complaints.

Exclusion Criteria

Concurrent medication likely to affect cognitive performance pregnancy or possible pregnancy history of drug or alcohol abuse or dependence recent head injury (in the last 3 months) history of seizure or stroke.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal do Piauí

OTHER

Sponsor Role lead

Responsible Party

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Fuad Ahmad Hazime

Assistant Professor - Physical Therapy Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fuad Hazime, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Piaui

Locations

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Department of Physical Therapy. Federal University of Piaui

Parnaíba, Piauí, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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1.584.966

Identifier Type: -

Identifier Source: org_study_id