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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Procedure: Transcranial direct current stimulation (tDCS); Procedure: Peripheral electrical stimulation (PES); Procedure: Sham tDCS

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Polyann Cavalcante, Msc; Phone Number: +55 86 3323-5209; Email: polyannacavalcante@gmail.com

Study Locations

• Brazil
  • Piauí
    • Parnaíba, Piauí, Brazil, 64202020
      • Department of Physical Therapy. Federal University of Piaui

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Procedure: 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.
Experimental: 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.	Procedure: 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.; 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.
Sham Comparator: 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).	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.
Experimental: Peripheral stimulation; Active peripheral electrical stimulation (PES). PES: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Visual analogue scale (VAS) for anxiety assesses anxiety symptoms that we tracked as possible confounding factor. The VAS for general anxiety is assessed by a horizontal 100-mm-long line. The extreme left end points to no anxiety, and the extreme right end to the worst anxiety possible.	Pre-test (before tDCS)
Depression	Beck depression inventory (BDI) for depressive symptoms that we tracked as possible confounding factor. The BDI is a tool of self-assessment of depression using a questionnaire with 21 items whose intensity varies from 0 to 3 (higher scores indicating more depressive symptoms).	Pre-test (before tDCS)
Pain catastrophizing	Catastrophizing pain scale that we tracked as possible confounding factor. The pain catastrophizing scale consists of 13 sentences describing pain-related thoughts or feelings. These are divided into 3 domains: rumination, magnification and helplessness. The total score on the questionnaire can lie between 0 - 52 where a higher score indicates higher levels of pain catastrophizing thoughts.	Pre-test (before tDCS)

Collaborators and Investigators

• Sponsor: Universidade Federal do Piauí
• Investigators: Principal Investigator: Fuad Hazime, PhD, Federal University of Piaui

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): November 27, 2021

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 26, 2018

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1.584.966

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No