Non-invasive Neurostimulation in Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Procedure: low-intensity transcranial electrical stimulation; Procedure: transcranial ultrasound

• Registration Number: NCT01615718
• Lead Sponsor: Spaulding Rehabilitation Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-06-08
• Study First Posted: 2012-06-11
• Study Start: 2013-09
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sham Electrical Stim/Sham Ultrasound	low-intensity transcranial electrical stimulation	Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
Sham Electrical Stim/Sham Ultrasound	transcranial ultrasound	Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
Active Electrical Stim/Active Ultrasound	transcranial ultrasound	Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Sham Electrical Stim/Active Ultrasound	transcranial ultrasound	Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Active Electrical Stim/Active Ultrasound	low-intensity transcranial electrical stimulation	Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Active Electrical Stim/Sham Ultrasound	low-intensity transcranial electrical stimulation	Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with sham (placebo) transcranial ultrasound for 20 minutes.
Active Electrical Stim/Sham Ultrasound	transcranial ultrasound	Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with sham (placebo) transcranial ultrasound for 20 minutes.
Sham Electrical Stim/Active Ultrasound	low-intensity transcranial electrical stimulation	Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Spaulding Rehabilitation Hospital; 🇺🇸 Boston, Massachusetts, United States