Healthy VolunteersPhase 2/3NCT03752502

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

A Phase 2/3 study testing Transcranial direct current stimulation (tDCS) and Peripheral electrical stimulation (PES) in people with Healthy Volunteers, run by Universidade Federal do Piauí at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Transcranial direct current stimulation (tDCS) and Peripheral electrical stimulation (PES)
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteBrazil
Study dates: 1 Dec 2018to 27 Nov 2021
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy subjects without medical complaints.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

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

Other trials in Brazil

About this study

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
Being tested: Transcranial direct current stimulation (tDCS), Peripheral electrical stimulation (PES), Sham tDCS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial direct current stimulation (tDCS)Procedure or surgery
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)Procedure or surgery
Peripheral electrical stimulation (PES) activates a complex neural network involving a series of neurotransmitters and receptors capable of promoting segmental and extrasegmental analgesia.
Sham tDCSProcedure or surgery
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.

Study groups in NCT03752502
Study group	Role	What they receive
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). Receives: 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. Receives: 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). Receives: Procedure: Sham tDCS
Peripheral stimulation	Experimental	Active peripheral electrical stimulation (PES). PES: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level. Receives: Procedure: Peripheral electrical stimulation (PES); Procedure: Sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

Pressure pain threshold
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.
Measured: 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).
Measured: Pre and Post-test (immediately after tDCS)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201827 Nov 2021

First posted26 Nov 2018
Study start1 Dec 2018
Primary completion30 Nov 2019
Study completion27 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03752502
Sponsor's protocol ID: 1.584.966
Status last verified: Nov 2023
First submitted: 21 Nov 2018
Last updated: 28 Nov 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Cerebral and Peripheral Electrical Stimulation on Conditioned Pain Modulation in Healthy Subjects.
ClinicalTrials.gov ID: NCT03752502
Acronym / sponsor ID: 1.584.966
Conditions: Healthy Volunteers
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Universidade Federal do PiauíUniversity, hospital or other
Study start: 1 Dec 2018 (actual)
Primary completion: 30 Nov 2019 (actual)
Study completion: 27 Nov 2021 (actual)
First posted: 26 Nov 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Cerebral stimulation	Experimental	Procedure: 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	Experimental	Procedure: Transcranial direct current stimulation (tDCS), Procedure: 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 comparator	Procedure: Sham tDCSSham 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	Experimental	Procedure: Peripheral electrical stimulation (PES), Procedure: Sham tDCSActive peripheral electrical stimulation (PES). PES: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Healthy subjects without medical complaints.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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 or surgery	Cerebral stimulation, Combined stimulation
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 or surgery	Combined stimulation, Peripheral stimulation
Sham tDCSTranscranial 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 or surgery	Peripheral stimulation, Sham cerebral stimulation

Primary outcome

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.
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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fuad Hazime, PhD principal investigator

Federal University of Piaui

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure pain threshold (time frame: Pre and Post-test (immediately after tDCS)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03752502.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.