NCT03759132

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2 parkinson-disease

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1.6 years

First QC Date

November 21, 2018

Last Update Submit

November 2, 2020

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Adverse effects

    Immediately after tDCS

Study Arms (2)

Anodal tDCS

EXPERIMENTAL

Bihemispheric tDCS applied over primary motor cortex. Dose: 2mA, 20 minutes

Procedure: Transcranial direct current stimulation

Sham tDCS

SHAM COMPARATOR

Bihemispheric tDCS applied over primary motor cortex. Dose: 2mA, 20 minutes (30s ON)

Procedure: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulationPROCEDURE

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

Anodal tDCSSham tDCS

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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-

You may not qualify if:

  • 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.-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy. Federal University of Piaui

Parnaíba, Piauí, 64202020, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor - Physical Therapy Department

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 29, 2018

Study Start

December 1, 2018

Primary Completion

June 30, 2020

Study Completion

October 30, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)