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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03752502
Enrollment
50
Registered
2018-11-26
Start date
2018-12-01
Completion date
2021-11-27
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

PROCEDURETranscranial 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.

PROCEDUREPeripheral 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.

PROCEDURESham 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.

Sponsors

Universidade Federal do Piauí
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pressure pain thresholdPre and Post-test (immediately after tDCS)Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.
Conditioned pain modulationPre 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

MeasureTime frameDescription
AnxietyPre-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.
DepressionPre-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).
Pain catastrophizingPre-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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026