Effects of Transcranial Direct Current Stimulation on Postural Control

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03759132
• Other study ID #: tDCS in Parkinson's Disease
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 1, 2018
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2020
• Source: Universidade Federal do Piauí
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.-

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
Brazil	Department of Physical Therapy. Federal University of Piaui	Parnaíba	Piauí

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Piauí

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse effects	Adverse effects will be evaluated using structured questionnaire	Immediately after tDCS
Primary	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)
Primary	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)
Primary	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)