Effects of Non-invasive Neurostimulation Methods on Motor Function in Parkinson's Disease Patients.

Spaulding Rehabilitation Hospital1 site in 1 country48 target enrollmentSeptember 2013

ConditionsParkinson's Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Parkinson's Disease
Sponsor: Spaulding Rehabilitation Hospital
Enrollment: 48
Locations: 1
Primary Endpoint: Changes in Motor Function
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

April 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Spaulding Rehabilitation Hospital

Responsible Party

Principal Investigator

Felipe Fregni

Principal Investigator

Spaulding Rehabilitation Hospital

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.

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.