Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability.
Running, not enrolling · Not applicable · Has a placebo group
Conditions studied: Parkinson Disease
In brief
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)
Key facts
- Study ID
- NCT03981055
- Run by
- Spaulding Rehabilitation Hospital
- People needed
- 40
- Starts
- 2020-01-23
- Expected to finish
- 2026-10-30
- Last updated by the study team
- 2026-03-03
Who can join
Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Spaulding Rehabilitation Network Research Institute — Charlestown, Massachusetts, United States
Full record on ClinicalTrials.gov
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