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Lack of funding and did not complete enrollment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham tDCS | Sham Comparator | Sham transcranial direct current stimulation where current will be reduced to zero after standardized ramp up to 2 mA |
|
| Active tDCS | Experimental | Transcranial direct current stimulation according to protocol maintained for 30 minutes after ramping up to 2 mA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 months |
| Subjective Depression Severity rated via self-report on depression inventory |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Mills, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital / Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
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|
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Subjective severity of depression as measured via self-reported Beck Depression Inventory - II |
| 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) | 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. | 1 month |
| Performance on abbreviated cognitive battery | Objective improvement on measures of attention, verbal fluency, working memory and recall by various bedside cognitive tests | 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. | 1 month |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003863 | Depression |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D046690 | Deep Brain Stimulation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D013514 | Surgical Procedures, Operative |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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