Parkinson DiseasePhase 2/3NCT03759132
Effects of Transcranial Direct Current Stimulation on Postural Control
A Phase 2/3 study testing Transcranial direct current stimulation in people with Parkinson Disease, run by Universidade Federal do Piauí at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2018to 30 Oct 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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-
Who cannot join
- 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.-
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Physical Therapy. Federal University of Piaui
Parnaíba, Piauí, 64202020
About this study
Official title: Effects of Transcranial Direct Current Stimulation on Postural Control: a Double-blind Randomized Controlled Trial.
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.
- Conditions
- Parkinson Disease
- Being tested
- Transcranial direct current stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationProcedure or surgery
Transcranial direct current stimulation is a noninvasive technique of neuronal modulation that has been used in different chronic neurological conditions, including Parkinson's disease.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Experimental | Bihemispheric tDCS applied over primary motor cortex.
Dose: 2mA, 20 minutes Receives: Procedure: Transcranial direct current stimulation |
| Sham tDCS | Sham comparator | Bihemispheric tDCS applied over primary motor cortex.
Dose: 2mA, 20 minutes (30s ON) Receives: Procedure: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Baseline and Post-tDCS (immediately after tDCS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Dec 2018
- Primary completion30 Jun 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Piauí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuad Ahmad Hazime, Universidade Federal do Piauí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759132
- Sponsor's protocol ID
- tDCS in Parkinson's Disease
- Status last verified
- Nov 2020
- First submitted
- 21 Nov 2018
- Last updated
- 4 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation on Postural Control: a Double-blind Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03759132
- Acronym / sponsor ID
- tDCS in Parkinson's Disease
- Conditions
- Parkinson Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidade Federal do PiauíUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Experimental | Procedure: Transcranial direct current stimulationBihemispheric tDCS applied over primary motor cortex. Dose: 2mA, 20 minutes |
| Sham tDCS | Sham comparator | Procedure: Transcranial direct current stimulationBihemispheric tDCS applied over primary motor cortex. Dose: 2mA, 20 minutes (30s ON) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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-
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulationTranscranial direct current stimulation is a noninvasive technique of neuronal modulation that has been used in different chronic neurological conditions, including Parkinson's disease. | Procedure or surgery | Anodal tDCS, Sham tDCS |
Primary outcome
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 - 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 - 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Transcranial direct current stimulation in people with Parkinson Disease, run by Universidade Federal do Piauí at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from COP - AP axis (time frame: Baseline and Post-tDCS (immediately after tDCS)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.