Idiopathic Parkinson DiseaseNCT02960464
tDCS for Treatment of Depression in Parkinson's Disease
A study testing Transcranial direct current stimulation in people with Idiopathic Parkinson Disease and Depression, run by Hospital Santa Marcelina at 1 site in Brazil.
Trial summary
Investigation of possible benefits of transcranial direct current stimulation (tDCS) as a treatment of depression in patients with Parkinson's Disease, through a randomized placebo-controlled clinical trial. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Idiopathic Parkinson Disease, Depression
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2016to Jun 2018
- Phase
- Interventional
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's Disease
- Geriatric Depression Scale - 15 higher that 5
- Major Depression Disorder
Who cannot join
- CNS disease other than Parkinson's Disease (i.e. epilepsy, stroke)
- Mental disorder other than depression on anxiety disorder (i.e. bipolar disorder, schizophrenia)
- Previous neurosurgical intervention (i.e. DBS)
- Current use of antidepressant drug
- High suicidality risk
- Limited capacity of understanding written and spoken Portuguese
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Santa Marcelina
São Paulo, São Paulo
Pedro Gordon, MD, dr.pedrogordon@gmail.com
Maria Sheila Rocha, MD, PhD, msrocha@uol.com.br
About this study
Official title: Transcranial Direct Current Stimulation for Treatment of Depression in Parkinson's Disease, a Randomized Placebo-controlled Clinical Trial
Investigation of possible benefits of transcranial direct current stimulation (tDCS) as a treatment of depression in patients with Parkinson's Disease, through a randomized placebo-controlled clinical trial.
Read the detailed description
We aim to investigate the effects of transcranial direct current stimulation (tDCS) as treatment for depression in patients with Parkinson's Disease. We have designed a clinical trial in which volunteers that fulfill inclusion criteria will receive 15 sessions of tDCS during 1 week (3 sessions a day, with 30 minutes interval in between). Subjects will be randomly allocated into two groups, one that will receive the real intervention (active) and the other that will receive the placebo intervention (sham). The collaborator in charge of administering the session will not participate in the evaluations, keeping both subjects and evaluators blinded to the nature of the sessions. Subjects will be evaluated at baseline, and after the end of sessions, 1 week, 4 weeks and 8 weeks, the latter being the main outcome.
We aim to enroll 50 subjects, 25 for each arm. The sample size calculation took into consideration previous clinical trials using tDCS for depression in different settings.
- Conditions
- Idiopathic Parkinson Disease, Depression
- Being tested
- Transcranial direct current stimulation, Sham Transcranial direct current stimulation
- Keywords
- Parkinson Disease, Depression, Transcranial Direct Current Stimulation, Neuromodulation
- Medical subject headings
- Parkinson Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham Transcranial direct current stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Active comparator | Active sessions will involve the placement of the anode over the scalp corresponding to the F3 (10-20 EEG system), and cathode over F4. Current intensity will be 2mA, and the stimulation will last for 20 minutes. Receives: Device: Transcranial direct current stimulation |
| Sham Arm | Sham comparator | Sham stimulation will follow the same procedure as the Active, however after 30 seconds of stimulation, the current is turned off, mimicking the initial sensation of the tDCS session but providing no clinical or physiological effect. Receives: Device: Sham Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression
Measured: 8 weeks
Secondary outcomes (7)
Montgomery-Åsberg Depression Rating Scale
Measured: 8 weeks
Mini-Mental State Examination
Measured: 8 weeks
Hamilton Anxiety Rating Scale
Measured: 8 weeks
Geriatric Depression Scale -15
Measured: 8 weeks
Parkinson's Disease Questionnaire - 39
Measured: 8 weeks
Lille apathy rating scale
Measured: 8 weeks
Quantitative EEG
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Santa Marcelina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Caldana Gordon, Hospital Santa Marcelina
- Investigators
- Maria Sheila Rocha, MD, PhD, Study director, Hospital Santa Marcelina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960464
- Sponsor's protocol ID
- HSMarcelina
- Status last verified
- Nov 2016
- First submitted
- 8 Nov 2016
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation for Treatment of Depression in Parkinson's Disease, a Randomized Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02960464
- Acronym / sponsor ID
- HSMarcelina
- Conditions
- Idiopathic Parkinson Disease, Depression
- Keywords
- Parkinson Disease, Depression, Transcranial Direct Current Stimulation, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Santa MarcelinaUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jun 2018 (estimated)
- First posted
- 9 Nov 2016 (estimated)
- 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.
Investigation of possible benefits of transcranial direct current stimulation (tDCS) as a treatment of depression in patients with Parkinson's Disease, through a randomized placebo-controlled clinical trial.
Detailed description
We aim to investigate the effects of transcranial direct current stimulation (tDCS) as treatment for depression in patients with Parkinson's Disease. We have designed a clinical trial in which volunteers that fulfill inclusion criteria will receive 15 sessions of tDCS during 1 week (3 sessions a day, with 30 minutes interval in between). Subjects will be randomly allocated into two groups, one that will receive the real intervention (active) and the other that will receive the placebo intervention (sham). The collaborator in charge of administering the session will not participate in the evaluations, keeping both subjects and evaluators blinded to the nature of the sessions. Subjects will be evaluated at baseline, and after the end of sessions, 1 week, 4 weeks and 8 weeks, the latter being the main outcome.
We aim to enroll 50 subjects, 25 for each arm. The sample size calculation took into consideration previous clinical trials using tDCS for depression in different settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Active comparator | Device: Transcranial direct current stimulationActive sessions will involve the placement of the anode over the scalp corresponding to the F3 (10-20 EEG system), and cathode over F4. Current intensity will be 2mA, and the stimulation will last for 20 minutes. |
| Sham Arm | Sham comparator | Device: Sham Transcranial direct current stimulationSham stimulation will follow the same procedure as the Active, however after 30 seconds of stimulation, the current is turned off, mimicking the initial sensation of the tDCS session but providing no clinical or physiological effect. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic Parkinson's Disease
- Geriatric Depression Scale - 15 higher that 5
- Major Depression Disorder
Key exclusion criteria (6 listed)
- CNS disease other than Parkinson's Disease (i.e. epilepsy, stroke)
- Mental disorder other than depression on anxiety disorder (i.e. bipolar disorder, schizophrenia)
- Previous neurosurgical intervention (i.e. DBS)
- Current use of antidepressant drug
- High suicidality risk
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 stimulation | Device | Active Arm |
| Sham Transcranial direct current stimulation | Device | Sham Arm |
Primary outcome
Hamilton Rating Scale for Depression
Time frame: 8 weeks
7 secondary outcomes
Montgomery-Åsberg Depression Rating Scale
Time frame: 8 weeks
Mini-Mental State Examination
Time frame: 8 weeks
Hamilton Anxiety Rating Scale
Time frame: 8 weeks
Geriatric Depression Scale -15
Time frame: 8 weeks
Parkinson's Disease Questionnaire - 39
Time frame: 8 weeks
Lille apathy rating scale
Time frame: 8 weeks
Quantitative EEG
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
- 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.
Maria Sheila Rocha, MD, PhD study director
Hospital Santa Marcelina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Idiopathic Parkinson Disease and Depression, run by Hospital Santa Marcelina 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 3 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: status not confirmed, as of the sponsor's last update on 10 Nov 2016. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamana Barbosa (2070-6000, jamana.bp@ig.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for Depression (time frame: 8 weeks). 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 10 Nov 2016.