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

Not Applicable

Active, not recruiting

• Conditions: Parkinson Disease
• Interventions: Other: Physical Therapy

• Registration Number: NCT03981055
• Lead Sponsor: Spaulding Rehabilitation Hospital

Brief 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)

Detailed 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.

Study Timeline

• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-10
• Study Start: 2020-01-23
• Primary Completion: 2024-04-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham TDCS and Sham TUS	Physical Therapy	Sham TDCS and Sham TUS for 20 min
Active tDCS and Active TUS	Physical Therapy	Active tDCS and Active TUS for 20 min

Primary Outcome Measures

Name	Time	Method
Change in postural sway	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.

Secondary Outcome Measures

Name	Time	Method
Unified Parkinson's Disease Rating Scale (UPDRS)	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.
Leg Agility	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.
Balance	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.
Arising from a chair	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.
Gait	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
Toe tapping	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.

Trial Locations

Locations (1)

Spaulding Rehabilitation Network Research Institute; 🇺🇸 Charlestown, Massachusetts, United States