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Non-invasive Neurostimulation in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT01615718
Recruitment Status : Recruiting
First Posted : June 11, 2012
Last Update Posted : March 21, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Parkinson's Disease Procedure: low-intensity transcranial electrical stimulation Procedure: transcranial ultrasound

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Non-invasive Neurostimulation Methods on Motor Function in Parkinson's Disease Patients.
Study Start Date : September 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Active Electrical Stim/Active Ultrasound
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
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.
Procedure: 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.
Sham Comparator: Sham Electrical Stim/Sham Ultrasound
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.
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.
Procedure: 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.
Active Comparator: Active Electrical Stim/Sham Ultrasound
Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with sham (placebo) transcranial ultrasound for 20 minutes.
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.
Procedure: 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.
Active Comparator: Sham Electrical Stim/Active Ultrasound
Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.
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.
Procedure: 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.


Outcome Measures

Primary Outcome Measures :
  1. Changes in Motor Function [ Time Frame: 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 :
  1. Safety [ Time Frame: 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

  2. Neurophysiological Changes [ Time Frame: Measured for approximately 2 months ]
    We will also use transcranial magnetic stimulation (TMS) and Doppler Ultrasound to assess electrophysiology and cerebral bloodflow markers.


Eligibility Criteria

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615718


Contacts
Contact: Felipe Fregni, MD, PhD, MPH 617-952-6156 ffregni@partners.org
Contact: Melanie French, BS 617-952-6151 mnfrench@partners.org

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Boston, Massachusetts, United States, 02144
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
National Institute of Neurological Disorders and Stroke (NINDS)
Highland Instruments, Inc.
Investigators
Principal Investigator: Timothy Wagner, PhD Highland Instruments, Inc.
Principal Investigator: Felipe Fregni, MD, PhD, MPH Spaulding Rehabilitation Hospital
More Information

Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01615718     History of Changes
Other Study ID Numbers: 2012-p-001120
1R44NS080632 ( U.S. NIH Grant/Contract )
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Felipe Fregni, Spaulding Rehabilitation Hospital:
noninvasive stimulation
motor function
transcranial stimulation
transcranial ultrasound
brain stimulation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases