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Non-invasive Neurostimulation in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
low-intensity transcranial electrical stimulation
transcranial ultrasound
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring noninvasive stimulation, motor function, transcranial stimulation, transcranial ultrasound, brain stimulation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Spaulding Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Active Comparator

Active Comparator

Arm Label

Active Electrical Stim/Active Ultrasound

Sham Electrical Stim/Sham Ultrasound

Active Electrical Stim/Sham Ultrasound

Sham Electrical Stim/Active Ultrasound

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Neurophysiological Changes
We will also use transcranial magnetic stimulation (TMS) and Doppler Ultrasound to assess electrophysiology and cerebral bloodflow markers.

Full Information

First Posted
May 30, 2012
Last Updated
January 26, 2021
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Highland Instruments, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01615718
Brief Title
Non-invasive Neurostimulation in Parkinson's Disease
Official Title
Effects of Non-invasive Neurostimulation Methods on Motor Function in Parkinson's Disease Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Highland Instruments, Inc.

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
noninvasive stimulation, motor function, transcranial stimulation, transcranial ultrasound, brain stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Electrical Stim/Active Ultrasound
Arm Type
Experimental
Arm Description
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Arm Title
Sham Electrical Stim/Sham Ultrasound
Arm Type
Sham Comparator
Arm Description
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
Arm Title
Active Electrical Stim/Sham Ultrasound
Arm Type
Active Comparator
Arm Description
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with sham (placebo) transcranial ultrasound for 20 minutes.
Arm Title
Sham Electrical Stim/Active Ultrasound
Arm Type
Active Comparator
Arm Description
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Intervention Type
Procedure
Intervention Name(s)
low-intensity transcranial electrical stimulation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
transcranial ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Motor Function
Description
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.
Time Frame
Measured for approximately 2 months
Secondary Outcome Measure Information:
Title
Safety
Description
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
Time Frame
Measured for approximately 2 months
Title
Neurophysiological Changes
Description
We will also use transcranial magnetic stimulation (TMS) and Doppler Ultrasound to assess electrophysiology and cerebral bloodflow markers.
Time Frame
Measured for approximately 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Wagner, PhD
Organizational Affiliation
Highland Instruments, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felipe Fregni, MD, PhD, MPH
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02144
Country
United States

12. IPD Sharing Statement

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Non-invasive Neurostimulation in Parkinson's Disease

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