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The purpose of this research is to determine whether repetitive sessions of transcranial direct current stimulation (tDCS) to the prefrontal cortex can enhance the cognitive, affective and motor functioning of those with Parkinson's Disease.
In this study we will compare active tDCS with sham tDCS. Each subject will receive two consecutive weeks of stimulation (Monday through Friday). A battery of neuropsychological and affective tests will be administered throughout the duration of the study.
Note that this study is a two-center study (the other center is Beth Israel Deaconess Medical Center - PI - Alvaro Pascual-Leone)
* Further study details are provided by Spaulding Rehabilitation Hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left active anodal DLPFC | Experimental | We will place the anodal electrode on the left dorsolateral prefrontal cortex. Stimulation will be given at 2 mA for a total of 20 mins for 10 consecutive sessions (Monday through Friday). |
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| Right active anodal DLPFC | Experimental | We will place the anodal electrode on the right dorsolateral prefrontal cortex. Stimulation will be given at 2 mA for a total of 20 mins for 10 consecutive sessions (Monday through Friday). |
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| Sham tDCS | Placebo Comparator | Sham tDCS: For sham-controlled tDCS subjects, the same montage will be used; however current will be applied for only 30 seconds. |
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| Open-Label Arm | Other | In addition to this study we will have an open label arm in which subjects who received sham stimulation through the course of the study will have the opportunity to receive active stimulation free of charge. The same parameters and identical procedures as is done in the original study will be used. Data will be collected as an open label, which will therefore provide additional information. Data obtained from this open label portion of the study will be kept separate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation | Device | Subjects will receive a total of 10 stimulation sessions on consecutive days, Monday- Friday for a total of two weeks. During each session, 2 mA of tDCS will be applied for 20 minutes over the left or right DLPFC (active or sham). |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of improvement in general motor functioning in patients with Parkinson's. | Measured by various indexes, including Unified Parkinson's Disease Rating Scale (UPDRS), Simple Reaction Time, 4-Choice Reaction Time, Purdue Pegboard Test, Finger tapping, walking time, buttoning up and supination-pronation. | after treatment (10 days) and at follow up (1 and 2 months after final stimulation) |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of improvement in cognitive functioning in the areas of: executive function, reasoning, visuospatial ability, and working memory for patients with Parkinson's. | Will be measured by The Stroop Test, Hooper Visual Organization Test, Digit Span Test, Trail Making Test B. | after treatment (10 days) and at follow up (1 and 2 months after final stimulation) |
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Inclusion Criteria:
Exclusion Criteria:
Features suggestive of other causes of parkinsonism/ parkinson-plus syndromes;
History of deep brain stimulation or ablation surgery, mass brain lesions;
History of schizophrenia, schizoaffective disorder, other psychosis, bipolar illness, alcohol/drug abuse within the past year;
Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality;
Contraindications to tDCS*
Unstable medical conditions (eg. uncontrolled diabetes, uncompensated cardiac issues heart failure, pulmonary issues, or chronic obstructive pulmonary disease)
Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Felipe Fregni, MD, PhD | Spaulding Rehabilitation Hospital | Principal Investigator |
| Ross Zafonte, DO | Spaulding Rehabilitation Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02114 | United States | ||
| Berenson Allen Center for Noninvasive Brain Stimulation |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
|
| Boston |
| Massachusetts |
| 02125 |
| United States |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |