Non-invasive Neurostimulation in Parkinson's Disease
Effects of Non-invasive Neurostimulation Methods on Motor Function in Parkinson's Disease Patients.
2 other identifiers
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2012
CompletedFirst Posted
Study publicly available on registry
June 11, 2012
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedJanuary 27, 2021
January 1, 2021
5.6 years
May 30, 2012
January 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Safety
Measured for approximately 2 months
Neurophysiological Changes
Measured for approximately 2 months
Study Arms (4)
Active Electrical Stim/Active Ultrasound
EXPERIMENTALSubjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Sham Electrical Stim/Sham Ultrasound
SHAM COMPARATORSubjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
Active Electrical Stim/Sham Ultrasound
ACTIVE COMPARATORSubjects will undergo active low-intensity transcranial electrical stimulation in conjunction with sham (placebo) transcranial ultrasound for 20 minutes.
Sham Electrical Stim/Active Ultrasound
ACTIVE COMPARATORSubjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02144, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy Wagner, PhD
Highland Instruments, Inc.
- PRINCIPAL INVESTIGATOR
Felipe Fregni, MD, PhD, MPH
Spaulding Rehabilitation Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 30, 2012
First Posted
June 11, 2012
Study Start
September 1, 2013
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
January 27, 2021
Record last verified: 2021-01