Non-invasive Neurostimulation in Parkinson's Disease
Parkinson's Disease
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring noninvasive stimulation, motor function, transcranial stimulation, transcranial ultrasound, brain stimulation
Eligibility Criteria
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.
Sites / Locations
- Spaulding Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Sham Comparator
Active Comparator
Active Comparator
Active Electrical Stim/Active Ultrasound
Sham Electrical Stim/Sham Ultrasound
Active Electrical Stim/Sham Ultrasound
Sham Electrical Stim/Active Ultrasound
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with sham (placebo) transcranial ultrasound for 20 minutes.
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.