Effects of Transcranial Pulse Stimulation in Parkinson's Disease

Launched by SPAULDING REHABILITATION HOSPITAL · Nov 4, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring whether a treatment called Transcranial Pulse Stimulation (TPS) can help improve symptoms in people with Parkinson's disease. The researchers want to see if TPS can make a difference in various areas, such as movement difficulties, thinking skills, mood, fatigue, freezing while walking, voice quality, and even smell and taste issues. Previous studies have shown that TPS might be beneficial for Alzheimer’s disease, and now they are investigating its potential for Parkinson's as well.

To participate in this trial, individuals should be between 40 and 90 years old and have a confirmed diagnosis of Parkinson's disease, specifically in stages 2 to 4. Participants need to have been taking stable Parkinson's medications for at least a month. Throughout the study, the safety and effectiveness of TPS will be closely monitored to see if it leads to any noticeable improvements in the symptoms mentioned. It’s important to note that certain medical conditions or history may disqualify someone from joining, so potential participants should discuss their eligibility with their doctor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of "probable" or "possible" 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.
• • 2. Age from 40 to 90 years old.
• • 3. Disease stages 2 to 4 based on the UPDRS scale subdomain V (or Hoehn and Yahr scale).
• • 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, brain ablation surgeries, or malignant mass brain lesions.
• • 3. History of schizophrenia, bipolar illness, or alcohol/drug abuse within the past six months.
• • 4. Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality.
• • 5. 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, CNS thrombosis, etc).
• • 6. Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, uncompensated pulmonary disease, or chronic obstructive pulmonary disease).
• • 7. Contraindications to MRI according to MGB 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).
• • 8. Pregnancy.
• • 9. 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.
• • 10. Bed- or wheelchair-bound patients.