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Non-invasive Neurostimulation in Parkinson's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Spaulding Rehabilitation Hospital
Sponsor:
Collaborators:
Highland Instruments, Inc.
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01615718
First received: May 30, 2012
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Parkinson's Disease
Procedure: low-intensity transcranial electrical stimulation
Procedure: transcranial ultrasound
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Non-invasive Neurostimulation Methods on Motor Function in Parkinson's Disease Patients.

Resource links provided by NLM:


Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Changes in Motor Function [ Time Frame: Measured for approximately 2 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Measured for approximately 2 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Measured for approximately 2 months ] [ Designated as safety issue: No ]
    We will also use transcranial magnetic stimulation (TMS) and Doppler Ultrasound to assess electrophysiology and cerebral bloodflow markers.


Estimated Enrollment: 48
Study Start Date: September 2013
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of "probable" PD, as defined by the current clinical criteria (Gelb D, Oliver E, Gilman S. Diagnostic Criteria for Parkinson Disease. Arch Neurol.1999;56:33-39);
  • 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, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615718

Contacts
Contact: Felipe Fregni, MD, PhD, MPH 617-952-6156 ffregni@partners.org
Contact: Kayleen M Weaver, BA 617-952-6151 kmweaver@partners.org

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Boston, Massachusetts, United States, 02144
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Highland Instruments, Inc.
Investigators
Principal Investigator: Timothy Wagner, PhD Highland Instruments, Inc.
Principal Investigator: Felipe Fregni, MD, PhD, MPH Spaulding Rehabilitation Hospital
  More Information

No publications provided

Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01615718     History of Changes
Other Study ID Numbers: 2012-p-001120, 1R44NS080632
Study First Received: May 30, 2012
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 24, 2014