Effects of Transcranial Direct Current Stimulation on Postural Control

Effects of Transcranial Direct Current Stimulation on Postural Control: a Double-blind Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Procedure: Transcranial direct current stimulation

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anodal tDCS; Bihemispheric tDCS applied over primary motor cortex. Dose: 2mA, 20 minutes	Procedure: Transcranial direct current stimulation; Transcranial direct current stimulation is a noninvasive technique of neuronal modulation that has been used in different chronic neurological conditions, including Parkinson's disease.
Sham Comparator: Sham tDCS; Bihemispheric tDCS applied over primary motor cortex. Dose: 2mA, 20 minutes (30s ON)	Procedure: Transcranial direct current stimulation; Transcranial direct current stimulation is a noninvasive technique of neuronal modulation that has been used in different chronic neurological conditions, including Parkinson's disease.

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	Adverse effects will be evaluated using structured questionnaire	Immediately after tDCS

Collaborators and Investigators

• Sponsor: Universidade Federal do Piauí

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: tDCS in Parkinson's Disease

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No