Parkinson's Disease
Conditions
Keywords
Parkinson, Transcranial direct current stimulation, Motor function, Cognitive function, Affective function
Brief summary
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.
Detailed description
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.
Interventions
DEVICETranscranial direct current stimulation
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).
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of probable PD, defined by the presence of at least 2 out of 3 cardinal motor features of PD (resting tremor, rigidity, and bradykinesia, plus a sustained and significant response to dopaminergic treatment); * Age 40 or over; * Taking stable medications for at least 30 days
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\* * metal in the head * implanted brain medical devices * Unstable medical conditions (eg. uncontrolled diabetes, uncompensated cardiac issues heart failure, pulmonary issues, or chronic obstructive pulmonary disease) * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of improvement in general motor functioning in patients with Parkinson's. | after treatment (10 days) and at follow up (1 and 2 months after final stimulation) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of improvement in cognitive functioning in the areas of: executive function, reasoning, visuospatial ability, and working memory for patients with Parkinson's. | after treatment (10 days) and at follow up (1 and 2 months after final stimulation) | Will be measured by The Stroop Test, Hooper Visual Organization Test, Digit Span Test, Trail Making Test B. |
Countries
United States
Outcome results
None listed