Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability.

Parkinson Disease Clinical Trial

Official title:

Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03981055
• Other study ID #: 2018P002733
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: Spaulding Rehabilitation Hospital
• Contact: Felipe Fregni, MD, PhD
• Phone: 6179526158
• Email: Fregni.Felipe[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial aims to understand the mechanism and to test whether transcranial direct current stimulation (tDCS) combined with transcranial ultrasound (TUS) (tDCS+TUS) combined with physical therapy (PT) will induce significant therapeutic effects in postural instability in Parkinson's disease (PT) patients. The investigators designed a double-blinded, placebo controlled, randomized study to investigate the effects of 2 weeks of TDCS+TUS on postural instability in PD patients receiving PT. (Followed by biweekly sessions for 2 more weeks in Phase II)

Description:

Current treatments for Parkinson's Disease (PD), including pharmacological (levodopa) and surgical (DBS) methods, have limited impact on postural instability. Physical therapy (PT) for PD is becoming increasingly used as a means to induce benefits on patient balance. However, limits in efficacy and consistency still exist. In this study, the investigators will test the effects of TDCS+TUS combined with PT on postural instability of PD patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

1. 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;

2. Complaints about balance impairment or postural instability due to PD (self-report);

3. Age from 40 to 90 years old;

4. Taking stable medications for PD for at least 30 days.

Exclusion Criteria:

1. Features suggestive of other causes of parkinsonism/Parkinson's-plus syndromes;

2. History of deep brain stimulation or brain ablation surgeries, malignant mass brain lesions;

3. History of schizophrenia, bipolar illness; history of alcohol/drug abuse within the past 6 months;

4. Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality;

5. Contraindications to transcranial brain stimulation or TUS, i.e. metal in the head, implanted brain medical devices, etc.;

6. Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, uncompensated pulmonary disease, or chronic obstructive pulmonary disease);

7. Pregnancy.

8. 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.

9. Recent (<= 2 months) or planned enrollment in an additional physician prescribed physical therapy program during their time in the trial.

10. Presence of another disorder that might have a significant impact on balance (as assessed by a co-investigator neurologist).

11. Bed or wheelchair-bound

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Active Comparator: Active tDCS and Active TUS
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.
• Sham Comparator: Sham TDCS and Sham TUS
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.

Other:
• Physical Therapy
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)

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Network Research Institute	Charlestown	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital	Highland Instruments, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postural sway	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	Unified Parkinson's Disease Rating Scale (UPDRS)	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
Secondary	Leg Agility	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
Secondary	Arising from a chair	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
Secondary	Balance	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
Secondary	Gait	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
Secondary	Toe tapping	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