Parkinson's Disease
Conditions
Keywords
noninvasive stimulation, motor function, transcranial stimulation, transcranial ultrasound, brain stimulation
Brief summary
In this study, the investigators aim to investigate the effects of non-invasive neurostimulation - low-intensity transcranial electrical stimulation in conjunction with transcranial ultrasound (TUS)- on the motor symptoms associated with Parkinson's disease. The investigators want to see if there is a difference between active and sham stimulation on these motor symptoms.
Interventions
PROCEDURElow-intensity transcranial electrical stimulation
Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation of up to 2mA. During active stimulation, the current will be active for 20 minutes - however, during sham stimulation (placebo) the current will not be active for the full 20 minutes.
PROCEDUREtranscranial ultrasound
Subjects will undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Highland Instruments, Inc.
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documentation of PD diagnosis from their clinician by either a letter or verification through their medical record * Research criteria of possible or probable PD, as defined by Gelb et al (Gelb D, Oliver E, Gilman S. Diagnostic Criteria for Parkinson Disease. Arch Neurol.1999;56:33-39)\[1\] * Age 40 or over; * Taking stable medications for at least 30 days
Exclusion criteria
* Features suggestive of other causes of parkinsonism/Parkinson's-plus syndromes; * History of deep brain stimulation or ablation surgery, mass brain lesions; * History of schizophrenia, schizoaffective disorder, other psychosis, episode of bipolar illness, alcohol/drug abuse within the past year; * Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidal; * Contraindications to transcranial brain stimulation or TUS, i.e. metal in the head, implanted brain medical devices, etc; * Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure, pulmonary issues, or chronic obstructive pulmonary disease); * Pregnancy. * Epilepsy or disorders that increase likelihood of seizures including: moderate or severe traumatic brain injury, congenital birth defects leading to seizures, brain tumor, metabolism disorders associated with seizures, and nonlacunar stroke.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Motor Function | Measured for approximately 2 months | We will measure motor symptoms using the Unified Parkinson's Disease Rating Scale (UPDRS), bradykinesia tests and walking tests. We will assess the changes in these scales from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | Measured for approximately 2 months | We will measure safety using a battery of electrophysiology, cognitive and neurological safety markers. We will use the Scales for Outcomes in PD-Cognitive (SCOPA-COg), the n-back working memory test, adverse effects questionnaire, electroencephalography (EEG) and a standardized neurological exam |
| Neurophysiological Changes | Measured for approximately 2 months | We will also use transcranial magnetic stimulation (TMS) and Doppler Ultrasound to assess electrophysiology and cerebral bloodflow markers. |
Countries
United States
Outcome results
None listed