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

NCT03752502 | Completed Phase 2

• 1 other identifier: 1.584.966
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Pressure pain threshold

  Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.

  Pre and Post-test (immediately after tDCS)

• Conditioned pain modulation

  Conditioned pain modulation paradigms consist of the evaluation of a painful test stimulus followed by a second evaluation either at the same time as a distant, painful conditioning stimulus. PPT will be evaluated following a conditioning stimulus condition (hand immersion in a cold water).

  Pre and Post-test (immediately after tDCS)

Other Outcomes (3)

• Anxiety

  Pre-test (before tDCS)

• Depression

  Pre-test (before tDCS)

• Pain catastrophizing

  Pre-test (before tDCS)

Study Arms (4)

Cerebral stimulation

EXPERIMENTAL

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

Procedure: Transcranial direct current stimulation (tDCS)

Combined stimulation

EXPERIMENTAL

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.

Procedure: Transcranial direct current stimulation (tDCS); Procedure: Peripheral electrical stimulation (PES)

Sham cerebral stimulation

SHAM COMPARATOR

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).

Procedure: Sham tDCS

Peripheral stimulation

EXPERIMENTAL

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

Procedure: Peripheral electrical stimulation (PES); Procedure: Sham tDCS

Interventions

Transcranial direct current stimulation (tDCS) 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.

Cerebral stimulation; Combined stimulation

Peripheral electrical stimulation (PES) PROCEDURE

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

Combined stimulation; Peripheral stimulation

Sham tDCS 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; Sham cerebral stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects without medical complaints.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Piauí: lead

Study Sites (1)

Department of Physical Therapy. Federal University of Piaui

Parnaíba, Piauí, 64202020, Brazil

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

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

Study Officials

• Fuad Hazime, PhD

  Federal University of Piaui

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Physical Therapy Department

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 26, 2018
• Study Start: December 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: November 27, 2021
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

BR (1)