Non-invasive Neurostimulation in Parkinson's Disease

Mass General Brigham

Status: Completed

Conditions: Parkinson's Disease

Treatments: Procedure: transcranial ultrasound; Procedure: low-intensity transcranial electrical stimulation

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01615718

1R44NS080632-01 (U.S. NIH Grant/Contract)

2012-p-001120

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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48 participants in 4 patient groups

Active Electrical Stim/Active Ultrasound

Experimental group

Description:

Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.

Treatment:

Procedure: low-intensity transcranial electrical stimulation

Procedure: transcranial ultrasound

Sham Electrical Stim/Sham Ultrasound

Sham Comparator group

Description:

Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.

Treatment:

Procedure: low-intensity transcranial electrical stimulation

Procedure: transcranial ultrasound

Active Electrical Stim/Sham Ultrasound

Active Comparator group

Description:

Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with sham (placebo) transcranial ultrasound for 20 minutes.

Treatment:

Procedure: low-intensity transcranial electrical stimulation

Procedure: transcranial ultrasound

Sham Electrical Stim/Active Ultrasound

Active Comparator group

Description:

Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.

Treatment:

Procedure: low-intensity transcranial electrical stimulation

Procedure: transcranial ultrasound