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

Phase 2

Completed

• Conditions: Healthy Volunteers
• Interventions: Procedure: Transcranial direct current stimulation (tDCS); Procedure: Sham tDCS; Procedure: Peripheral electrical stimulation (PES)

• Registration Number: NCT03752502
• Lead Sponsor: Universidade Federal do Piauí

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-26
• Study Start: 2018-12-01
• Primary Completion: 2019-11-30
• Study Completion: 2021-11-27
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cerebral stimulation	Transcranial direct current stimulation (tDCS)	Active transcranial direct current stimulation tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
Combined stimulation	Transcranial direct current stimulation (tDCS)	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.
Combined stimulation	Peripheral electrical stimulation (PES)	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.
Sham cerebral stimulation	Sham tDCS	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).
Peripheral stimulation	Peripheral electrical stimulation (PES)	Active peripheral electrical stimulation (PES). PES: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level.
Peripheral stimulation	Sham tDCS	Active peripheral electrical stimulation (PES). PES: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level.

Primary Outcome Measures

Name	Time	Method
Pressure pain threshold	Pre and Post-test (immediately after tDCS)	Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.
Conditioned pain modulation	Pre and Post-test (immediately after tDCS)	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).

Trial Locations

Locations (1)

Department of Physical Therapy. Federal University of Piaui; 🇧🇷 Parnaíba, Piauí, Brazil