Idiopathic Parkinson's DiseaseNCT03074812
Exploring Mechanisms for Neuropsychiatric Symptoms of Parkinson Disease Using Transcranial Direct Current Stimulation
A study testing Transcranial Direct Current Stimulation in people with Idiopathic Parkinson's Disease and Parkinson Disease, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study evaluates the effect of transcranial direct current stimulation (tDCS) on non-motor symptoms of Parkinson's disease, including depression and cognitive symptoms. Participants are randomized to receive active or sham tDCS for 30 minutes over 10 treatment sessions. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Idiopathic Parkinson's Disease, 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
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Oct 2028
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abel to provide written informed consent is obtained in the English language
- Age 18 to 95 years old
- Movement Disorder Society Clinical Diagnostic Criteria for probable idiopathic Parkinson disease
- Report disabling depressive or neuropsychiatric symptoms prior to study entry
- Capacity to understand the nature of the study;
Who cannot join
- Known structural brain disease such as a neoplasm, abscess etc.
- Pre-existing skull / scalp defects that would impede standardized electrode placement
- Current electronic or metal implants
- Diagnosis of Bipolar Disorder, Post-Traumatic Stress Disorder, a Psychotic Disorder or any other non-unipolar depressive disorder as a principal diagnosis in the 6 months prior to screening;
- Concurrent treatment with medication which may affect tDCS (benzodiazepines, anticonvulsants, dextromethorphan and pseudoephedrine)
- Endorse active suicidal ideation at enrollment or during any study visit, or have attempted suicide in the six months prior to screening;
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- History of substance abuse or dependence in the 2 months prior to screening;
- Considered to be at significant risk of committing homicide;
- Unstable medical condition;
- Score less than 22 on the Montreal Cognitive Assessment (MoCA)
- Women of childbearing potential who are pregnant or are considering becoming pregnant during the length of the study;
- There has been a change in their depression or psychotherapy treatment regimen in the 2 weeks preceding screening;
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Hospital / Johns Hopkins University
Baltimore, Maryland, 21287
About this study
This study evaluates the effect of transcranial direct current stimulation (tDCS) on non-motor symptoms of Parkinson's disease, including depression and cognitive symptoms. Participants are randomized to receive active or sham tDCS for 30 minutes over 10 treatment sessions.
- Being tested
- Transcranial Direct Current Stimulation
- 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.
Transcranial Direct Current StimulationDevice
Also called tDCS, Brain Stimulation, Neuromodulation
Transcranial direct current stimulation (tDCS) is a commonly used non-invasive form of brain stimulation for studying motor functions in health and disease [36]. It involves the attachment of surface electrodes to the scalp through which very small electric currents (1 or 2mA) are applied via a current regulated device. The currents do not produce any sensation. The applied current affects excitability of underlying neural tissue.
| Study group | Role | What they receive |
|---|---|---|
| Sham tDCS | Sham comparator | Sham transcranial direct current stimulation where current will be reduced to zero after standardized ramp up to 2 mA Receives: Device: Transcranial Direct Current Stimulation |
| Active tDCS | Experimental | Transcranial direct current stimulation according to protocol maintained for 30 minutes after ramping up to 2 mA Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Demonstrating improvements on Objective Rating Scales of Depression via structured interview
Primary outcome measure will be the number of participants who demonstrate remission of depressive symptoms OR improvement of 50% (i.e. response) on the Montgomery-Asberg Scale of Depression (MADRS)
Measured: 1 months
Secondary outcomes (6)
Apathy Scores as measure by a self-report scale (the Apathy Scale)
The dimensional degree of change in Apathy symptoms as assessed via the Apathy Scale, a subjective self-report tool of apathetic symptoms
Measured: 1 months
Subjective Depression Severity rated via self-report on depression inventory
Subjective severity of depression as measured via self-reported Beck Depression Inventory - II
Measured: 1 months
Subjective reactive to pleasure (i.e. improvement of anhedonia) as rated via self-report
Monitoring degree of change of hedonic-tone scores via the Snaith-Hamilton Pleasure Scale (SHAPS)
Measured: 1 month
Subjective improvement of Anxiety Symptoms via Rating Scale
The change in Parkinson Anxiety Scale (PAS) score per person and across sham v. experimental groups.
Measured: 1 month
Performance on abbreviated cognitive battery
Objective improvement on measures of attention, verbal fluency, working memory and recall by various bedside cognitive tests
Measured: 1 month
Improvement of Parkinsonian Motor Symptoms
Number of participants between arms and individual improvement of Movement Disorders Society Unified Parkinson Disease Rating Scale Part 3 (MDS-UPDRS Pt3) Score.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study startFeb 2016
- Primary completion28 Feb 2028 (estimated)
- Study completionOct 2028 (estimated)
Why it stopped: Lack of funding and did not complete enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelly Mills, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074812
- Sponsor's protocol ID
- IRB00087957
- Status last verified
- Feb 2026
- First submitted
- 2 Mar 2016
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Mechanisms for Neuropsychiatric Symptoms of Parkinson Disease Using Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT03074812
- Acronym / sponsor ID
- IRB00087957
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lack of funding and did not complete enrollment.
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 9 Mar 2017 (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.
This study evaluates the effect of transcranial direct current stimulation (tDCS) on non-motor symptoms of Parkinson's disease, including depression and cognitive symptoms. Participants are randomized to receive active or sham tDCS for 30 minutes over 10 treatment sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham tDCS | Sham comparator | Device: Transcranial Direct Current StimulationSham transcranial direct current stimulation where current will be reduced to zero after standardized ramp up to 2 mA |
| Active tDCS | Experimental | Device: Transcranial Direct Current StimulationTranscranial direct current stimulation according to protocol maintained for 30 minutes after ramping up to 2 mA |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Abel to provide written informed consent is obtained in the English language
- Age 18 to 95 years old
- Movement Disorder Society Clinical Diagnostic Criteria for probable idiopathic Parkinson disease
- Report disabling depressive or neuropsychiatric symptoms prior to study entry
- Capacity to understand the nature of the study;
Key exclusion criteria (12 listed)
- Known structural brain disease such as a neoplasm, abscess etc.
- Pre-existing skull / scalp defects that would impede standardized electrode placement
- Current electronic or metal implants
- Diagnosis of Bipolar Disorder, Post-Traumatic Stress Disorder, a Psychotic Disorder or any other non-unipolar depressive disorder as a principal diagnosis in the 6 months prior to screening;
- Concurrent treatment with medication which may affect tDCS (benzodiazepines, anticonvulsants, dextromethorphan and pseudoephedrine)
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 StimulationAlso: tDCS, Brain Stimulation, NeuromodulationTranscranial direct current stimulation (tDCS) is a commonly used non-invasive form of brain stimulation for studying motor functions in health and disease [36]. It involves the attachment of surface electrodes to the scalp through which very small electric currents (1 or 2mA) are applied via a current regulated device. The currents do not produce any sensation. The applied current affects excitability of underlying neural tissue. | Device | Active tDCS, Sham tDCS |
Primary outcome
Number of Participants Demonstrating improvements on Objective Rating Scales of Depression via structured interview
Time frame: 1 months
Primary outcome measure will be the number of participants who demonstrate remission of depressive symptoms OR improvement of 50% (i.e. response) on the Montgomery-Asberg Scale of Depression (MADRS)
6 secondary outcomes
Apathy Scores as measure by a self-report scale (the Apathy Scale)
Time frame: 1 months
Subjective Depression Severity rated via self-report on depression inventory
Time frame: 1 months
Subjective reactive to pleasure (i.e. improvement of anhedonia) as rated via self-report
Time frame: 1 month
Subjective improvement of Anxiety Symptoms via Rating Scale
Time frame: 1 month
Performance on abbreviated cognitive battery
Time frame: 1 month
Improvement of Parkinsonian Motor Symptoms
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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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.
Kelly Mills, M.D. principal investigator
Johns Hopkins University
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's Disease and Parkinson Disease, run by Johns Hopkins University at 1 site in United States.
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 5 inclusion and 12 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: paused, as of the sponsor's last update on 23 Feb 2026. 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 United States. 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?
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?
Number of Participants Demonstrating improvements on Objective Rating Scales of Depression via structured interview (time frame: 1 months). 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 23 Feb 2026.