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

Mass General Brigham

Status: Active, not recruiting

Conditions: Parkinson Disease

Treatments: Device: Active Comparator: Active tDCS and Active TUS; Other: Physical Therapy; Device: Sham Comparator: Sham TDCS and Sham TUS

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03981055

R44NS110237 (U.S. NIH Grant/Contract)

2018P002733

Details and patient eligibility

About

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)

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Active tDCS and Active TUS

Experimental group

Description:

Active tDCS and Active TUS for 20 min

Treatment:

Other: Physical Therapy

Device: Active Comparator: Active tDCS and Active TUS

Sham TDCS and Sham TUS

Sham Comparator group

Description:

Sham TDCS and Sham TUS for 20 min

Treatment:

Device: Sham Comparator: Sham TDCS and Sham TUS

Other: Physical Therapy