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

Universidade Federal do Piauí

Status and phase: Completed; Phase 3; Phase 2

Conditions: Healthy Volunteers

Treatments: Procedure: Peripheral electrical stimulation (PES); Procedure: Sham tDCS; Procedure: Transcranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03752502

1.584.966

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

50 participants in 4 patient groups

Cerebral stimulation

Experimental group

Description:

Active transcranial direct current stimulation tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).

Treatment:

Procedure: Transcranial direct current stimulation (tDCS)

Combined stimulation

Experimental group

Description:

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.

Treatment:

Procedure: Peripheral electrical stimulation (PES)

Procedure: Transcranial direct current stimulation (tDCS)

Sham cerebral stimulation

Sham Comparator group

Description:

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).

Treatment:

Procedure: Sham tDCS

Peripheral stimulation

Experimental group

Description:

Active peripheral electrical stimulation (PES). PES: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level.

Treatment:

Procedure: Peripheral electrical stimulation (PES)

Procedure: Sham tDCS