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Completed

NCT Number: NCT03759132

Effects of Transcranial Direct Current Stimulation on Postural Control

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Physical Therapy. Federal University of Piaui

Parnaíba, Piauí, 64202020, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.-

Treatment and study plan

transcranial direct current stimulation

Procedure

Transcranial direct current stimulation is a noninvasive technique of neuronal modulation that has been used in different chronic neurological conditions, including Parkinson's disease.

Primary outcomes

  1. Change from COP - AP axis

    Time frame: 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.

  2. Change from COP - ML axis

    Time frame: 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.

  3. Change from COP - area

    Time frame: 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).

Other outcomes

  1. Adverse effects

    Time frame: Immediately after tDCS

    Adverse effects will be evaluated using structured questionnaire

Sponsors and collaborators

Lead sponsor

Universidade Federal do Piauí

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2018
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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