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Clinical Trials/NCT03759132
NCT03759132
Completed
Phase 2

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

Universidade Federal do Piauí1 site in 1 country18 target enrollmentDecember 1, 2018

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Universidade Federal do Piauí
Enrollment
18
Locations
1
Primary Endpoint
Change from COP - ML axis
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2018
End Date
October 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Universidade Federal do Piauí
Responsible Party
Principal Investigator
Principal Investigator

Fuad Ahmad Hazime

Assistant Professor - Physical Therapy Department

Universidade Federal do Piauí

Eligibility Criteria

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.-

Outcomes

Primary Outcomes

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.

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.

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).

Study Sites (1)

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