- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03981055
Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Felipe Fregni, MD, PhD
- Phone Number: 6179526158
- Email: Fregni.Felipe@mgh.harvard.edu
Study Contact Backup
- Name: Elly Pichardo, MD
- Phone Number: 617-952-6154
- Email: epichardo@partners.org
Study Locations
-
-
Massachusetts
-
Charlestown, Massachusetts, United States, 02129
- Recruiting
- Spaulding Rehabilitation Network Research Institute
-
Contact:
- Elly Pichardo, MD
- Phone Number: 617-952-6154
- Email: epichardo@partners.org
-
Contact:
- Felipe Fregni, MD PhD MPH
- Phone Number: 617-952-6156
- Email: ffregni@partners.org
-
Principal Investigator:
- Felipe Fregni, MD PhD MPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of "probable" or "possible" PD, as defined by the current clinical criteria (Gelb D, Oliver E, Gilman S. Diagnostic Criteria for Parkinson's Disease. Arch Neurol.1999;56:33-39) as confirmed by co-investigator neurologist, or confirmation via medical records or a letter from patient physician;
- Complaints about balance impairment or postural instability due to PD (self-report);
- Age from 40 to 90 years old;
- Taking stable medications for PD for at least 30 days.
Exclusion Criteria:
- Features suggestive of other causes of parkinsonism/Parkinson's-plus syndromes;
- History of deep brain stimulation or brain ablation surgeries, malignant mass brain lesions;
- History of schizophrenia, bipolar illness; history of alcohol/drug abuse within the past 6 months;
- Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality;
- 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, uncompensated pulmonary disease, or chronic obstructive pulmonary disease);
- Pregnancy.
- Epilepsy or disorders that significantly increase likelihood of seizures including: severe traumatic brain injury, congenital birth defects leading to seizures, brain tumor, metabolic disorders associated with seizures, intracranial or subarachnoid hemorrhage, and nonlacunar strokes.
- Recent (<= 2 months) or planned enrollment in an additional physician prescribed physical therapy program during their time in the trial.
- Presence of another disorder that might have a significant impact on balance (as assessed by a co-investigator neurologist).
- Bed or wheelchair-bound
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active tDCS and Active TUS
Active tDCS and Active TUS for 20 min
|
Device: Transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.
All subjects will enroll in a conventional PT balance and gait focused training program, and will receive PT 3x/week over the two weeks of stimulation for 45 minutes following the stimulation sessions when applicable.
(And during the biweekly sessions for Phase II)
|
Sham Comparator: Sham TDCS and Sham TUS
Sham TDCS and Sham TUS for 20 min
|
All subjects will enroll in a conventional PT balance and gait focused training program, and will receive PT 3x/week over the two weeks of stimulation for 45 minutes following the stimulation sessions when applicable.
(And during the biweekly sessions for Phase II)
Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in postural sway
Time Frame: 1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
|
Postural sway will be assessed through biomechanical assessments using a set of integrated sensors including accelerometers, gyroscopes, force sensors, and motion-capture cameras.
|
1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: 1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
|
Motor function (including tremor, bradykinesia, postural instability and gait), non-motor symptoms, activities of daily living and complications of therapy will be investigated per UPDRS (parts I-IV); staging of PD and ability to perform activities of daily living will also be investigated via UPDRS parts V and VI.
We already have experience using this assessment in several previous brain stimulation PD studies.
|
1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
|
Leg Agility
Time Frame: 1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
|
kinematic changes will be assessed with kinematic metrics (e.g., speed (m/s)) taken with a biomechanical assessment suite throughout the study.
|
1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
|
Arising from a chair
Time Frame: 1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
|
kinematic changes will be assessed with kinematic metrics (e.g., time to complete task) taken with a biomechanical assessment suite throughout the study.
|
1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
|
Balance
Time Frame: 1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
|
kinematic changes will be assessed with kinematic metrics taken during a modified Romberg exam (e.g., change in center of pressure over a fixed time interval (cm)) with a biomechanical assessment suite throughout the study.
|
1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
|
Gait
Time Frame: 1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
|
changes in the walking speed, gait asymmetry, stride length, walking smoothness, and gait freezing kinematic characteristics (e.g., m/s) will be assessed with a biomechanical assessment suite throughout the study
|
1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
|
Toe tapping
Time Frame: 1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
|
kinematic changes will be assessed with kinematic metrics (e.g., speed (m/s)) taken with a biomechanical assessment suite throughout the study.
|
1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Felipe Fregni, MD, PhD, Spaulding Rehabilitation Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018P002733
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on Active Comparator: Active tDCS and Active TUS
-
Case Western Reserve UniversityHighland Instruments, Inc.Recruiting
-
Case Western Reserve UniversityHighland Instruments, Inc.RecruitingDiabetic Neuropathies | Chronic PainUnited States
-
Case Western Reserve UniversityHighland Instruments, Inc.RecruitingDiabetic Neuropathies | Chronic PainUnited States
-
University Health Network, TorontoRecruitingParkinson Disease | Dystonia | Essential TremorCanada
-
Duke UniversityEnrolling by invitationLong COVID | Long Covid19 | Long Covid-19United States
-
Duke UniversityEnrolling by invitationLong COVID | Long Covid19 | Long Covid-19United States
-
University Health Network, TorontoActive, not recruitingParkinson Disease | DystoniaCanada
-
University of New MexicoNational Institutes of Health (NIH); National Institute of General Medical... and other collaboratorsRecruitingStroke | AphasiaUnited States
-
University of MichiganNational Institute of Neurological Disorders and Stroke (NINDS)TerminatedMigraineUnited States
-
Bambino Gesù Hospital and Research InstituteCompleted