Effects of Transcranial Direct Current Stimulation on Postural Control

Phase 2

Completed

• Conditions: Parkinson Disease
• Interventions: Procedure: Transcranial direct current stimulation

• Registration Number: NCT03759132
• Lead Sponsor: Universidade Federal do Piauí

Brief Summary

Parkinson's disease is a progressive, degenerative neurological disease associated with profound changes in the quality of life of its survivors. Recent evidence has demonstrated the potential use of transcranial direct current stimulation (tDCS) to modulate cerebral excitability and movement control in neurological chronic conditions. However, few studies have investigated the effects of tDCS on postural control in patients with Parkinson's disease. This study aims to investigate the effect of bihemispheric tDCS on postural control in people with Parkinson's disease. Participants will be randomized to receive a single session of anodal and sham bihemispheric tDCS (7 days between each type of stimulation).

Primary clinical outcome (balance) will be collected before and immediately after tDCS. The data will be collected by a blind examiner to the treatment allocation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-29
• Study Start: 2018-12-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-10-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Medical diagnosis of idiopathic Parkinson's disease present for at least 12 months

In clinical follow-up and pharmacological treatment by a responsible physician

Parkinson's classification of 1.5-3 according to the Hoehn and Yahr scale

Signing of the free and informed consent form-

Exclusion Criteria

Use any associated orthopedic device to aid gait or balance control

Signs of severe dementia (evaluated by the Mini-Mental State Examination - MMSE)

Diagnosis of other neurological disorders (including those of central and peripheral nature)

Previous treatment with tDCS

Medical diagnosis of psychiatric illnesses with the use of centrally acting medications (depressants)

The use of pacemakers or other implanted devices.-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Anodal tDCS	Transcranial direct current stimulation	Bihemispheric tDCS applied over primary motor cortex. Dose: 2mA, 20 minutes
Sham tDCS	Transcranial direct current stimulation	Bihemispheric tDCS applied over primary motor cortex. Dose: 2mA, 20 minutes (30s ON)

Primary Outcome Measures

Name	Time	Method
Change from COP - ML axis	Baseline and Post-tDCS (immediately after tDCS)	Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in Mediolateral (ML) axis in centimeters.
Change from COP - AP axis	Baseline and Post-tDCS (immediately after tDCS)	Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in antero-posterior (AP) axis in centimeters.
Change from COP - area	Baseline and Post-tDCS (immediately after tDCS)	Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) area (cm²).

Trial Locations

Locations (1)

Department of Physical Therapy. Federal University of Piaui; 🇧🇷 Parnaíba, Piauí, Brazil