NCT01615718CompletedNot Applicable
Effects of Non-invasive Neurostimulation Methods on Motor Function in Parkinson's Disease Patients.
Spaulding Rehabilitation Hospital2 sites in 1 country48 target enrollmentStarted: September 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Changes in Motor Function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Changes in Motor Function
Time Frame: 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 Outcomes
- Safety(Measured for approximately 2 months)
- Neurophysiological Changes(Measured for approximately 2 months)
Investigators
Felipe Fregni
Principal Investigator
Spaulding Rehabilitation Hospital
Study Sites (2)
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