Non-invasive Neurostimulation in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615718
• Other study ID #: 2012-p-001120
• Secondary ID: 1R44NS080632-01
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: April 2019

Study information

• Verified date: January 2021
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Procedure:
• low-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.
• transcranial 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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital	Highland Instruments, Inc., National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Motor Function	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.	Measured for approximately 2 months
Secondary	Safety	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	Measured for approximately 2 months
Secondary	Neurophysiological Changes	We will also use transcranial magnetic stimulation (TMS) and Doppler Ultrasound to assess electrophysiology and cerebral bloodflow markers.	Measured for approximately 2 months