Effects of Transcranial Pulse Stimulation in Parkinson's Disease

Completed · Not applicable

Conditions studied: Parkinson

In brief

The investigators are studying if Transcranial Pulse Stimulation (TPS) can improve various symptoms, including movement problems, thinking abilities, mood, fatigue, freezing while walking, voice quality, and issues with smell and taste. Previous research suggests TPS might help in Alzheimer's disease and could be helpful for Parkinson's as well. Investigators will check if TPS is safe, practical, and if it makes a noticeable difference in these symptoms compared to before the treatment.

Key facts

Study ID

NCT06676995

Run by

Spaulding Rehabilitation Hospital

People needed

14

Starts

2024-12-31

Expected to finish

2025-07-30

Last updated by the study team

2026-08-10

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" Parkinson's Disease (PD), as defined by the current clinical criteria (52) or as confirmed by a co-investigator neurologist or confirmation via medical records or a letter from a patient's physician.
• Age from 40 to 90 years old.
• Disease stages 2 to 4 based on the UPDRS scale subdomain V (or Hoehn and Yahr scale).
• Taking stable medications for Parkinson's Disease 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, brain ablation surgeries, or malignant mass brain lesions.
• History of schizophrenia, bipolar illness, or alcohol/drug abuse within the past six months.
• Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality.
• Contraindications to transcranial brain stimulation (i.e., metal objects in the head, metal implanted brain medical devices, cortisone treatments within six weeks before the first stimulation session, central nervous system (CNS) thrombosis, etc).
• Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, uncompensated pulmonary disease, or chronic obstructive pulmonary disease).
• Contraindications to MRI according to Mass General Brigham screening in the Martinos Center (i.e., pacemaker, defibrillator or wires other than sternal wires, metallic foreign body in the eye, or drug infusion devices - if the models of these devices are not compatible with MRI).
• Pregnancy.
• Epilepsy or disorders that significantly increase the likelihood of seizures, including: (i) severe traumatic brain injury; (ii) congenital birth defects leading to seizures; (iii) brain tumor; (iv) metabolic disorders associated with seizures; (v) intracranial or subarachnoid hemorrhage; and (vi) non-lacunar strokes.
• Bed- or wheelchair-bound patients.

Where it is running

• Spaulding Rehabilitation Hospital — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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