Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability. (NCT03981055)
๐ฉบ Plain-English Summary (8th-Grade Level)
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)
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (12 items).
Location: Spaulding Rehabilitation Network Research Institute โ Charlestown, Massachusetts
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (1 Sites)
- Spaulding Rehabilitation Network Research Institute โ Charlestown, Massachusetts
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.