Back to resultsEffects of Transcranial Direct Current Stimulation on Postural Control
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
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.-
Sites / Locations
- Department of Physical Therapy. Federal University of Piaui
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Anodal tDCS
Sham tDCS
Arm Description
Bihemispheric tDCS applied over primary motor cortex. Dose: 2mA, 20 minutes
Bihemispheric tDCS applied over primary motor cortex. Dose: 2mA, 20 minutes (30s ON)
Outcomes
Primary Outcome Measures
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.
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.
Change from COP - area
Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) area (cm²).
Secondary Outcome Measures
Full Information
NCT ID
NCT03759132
First Posted
November 21, 2018
Last Updated
November 2, 2020
Sponsor
Universidade Federal do Piauí
1. Study Identification
Unique Protocol Identification Number
NCT03759132
Brief Title
Effects of Transcranial Direct Current Stimulation on Postural Control
Official Title
Effects of Transcranial Direct Current Stimulation on Postural Control: a Double-blind Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Piauí
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anodal tDCS
Arm Type
Experimental
Arm Description
Bihemispheric tDCS applied over primary motor cortex.
Dose: 2mA, 20 minutes
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Bihemispheric tDCS applied over primary motor cortex.
Dose: 2mA, 20 minutes (30s ON)
Intervention Type
Procedure
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
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 Outcome Measure Information:
Title
Change from COP - AP axis
Description
Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in antero-posterior (AP) axis in centimeters.
Time Frame
Baseline and Post-tDCS (immediately after tDCS)
Title
Change from COP - ML axis
Description
Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) in Mediolateral (ML) axis in centimeters.
Time Frame
Baseline and Post-tDCS (immediately after tDCS)
Title
Change from COP - area
Description
Postural instability will be evaluated using a force plate to record center of pressure displacement (COP) area (cm²).
Time Frame
Baseline and Post-tDCS (immediately after tDCS)
Other Pre-specified Outcome Measures:
Title
Adverse effects
Description
Adverse effects will be evaluated using structured questionnaire
Time Frame
Immediately after tDCS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.-
Facility Information:
Facility Name
Department of Physical Therapy. Federal University of Piaui
City
Parnaíba
State/Province
Piauí
ZIP/Postal Code
64202020
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Transcranial Direct Current Stimulation on Postural Control
We'll reach out to this number within 24 hrs