Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03752502
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
Fuad Ahmad Hazime, Universidade Federal do Piauí

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Procedure: Transcranial direct current stimulation (tDCS) Procedure: Peripheral electrical stimulation (PES) Procedure: Sham tDCS Phase 2 Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Cerebral and Peripheral Electrical Stimulation on Conditioned Pain Modulation in Healthy Subjects.
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : November 30, 2019
Estimated Study Completion Date : July 30, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Pressure pain threshold [ Time Frame: Pre and Post-test (immediately after tDCS) ]
    Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.

  2. Conditioned pain modulation [ Time Frame: 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).



Other Outcome Measures:
  1. Anxiety [ Time Frame: Pre-test (before tDCS) ]

    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.


  2. Depression [ Time Frame: Pre-test (before tDCS) ]

    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).


  3. Pain catastrophizing [ Time Frame: Pre-test (before tDCS) ]

    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.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752502


Contacts
Layout table for location contacts
Contact: Polyann Cavalcante, Msc +55 86 3323-5209 polyannacavalcante@gmail.com

Locations
Layout table for location information
Brazil
Department of Physical Therapy. Federal University of Piaui Recruiting
Parnaíba, Piauí, Brazil, 64202020
Contact: Polyanna Cavalcante, Msc         
Sponsors and Collaborators
Universidade Federal do Piauí
Investigators
Layout table for investigator information
Principal Investigator: Fuad Hazime, PhD Federal University of Piaui
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Fuad Ahmad Hazime, Assistant Professor - Physical Therapy Department, Universidade Federal do Piauí
ClinicalTrials.gov Identifier: NCT03752502    
Other Study ID Numbers: 1.584.966
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No