Transcranial Pulse Stimulation for Parkinson's Disease Symptoms

Parkinson's Disease: Overall Symptoms Improvement With Transcranial Pulse Stimulation (TPS)

This study is testing if a new treatment called Transcranial Pulse Stimulation can help improve symptoms like movement problems and mood in people with Parkinson's Disease.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 40 Years to 90 Years
• Sex: All
• Sponsor: Spaulding Rehabilitation Hospital (other)
• Locations: 1 site (Cambridge, Massachusetts)
• Trial ID: NCT06676995 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of Transcranial Pulse Stimulation (TPS) on various symptoms of Parkinson's Disease, including movement difficulties, cognitive function, mood, fatigue, and sensory issues. Participants will undergo TPS treatment to assess its safety and practicality, as well as its effectiveness in improving their symptoms compared to baseline measurements. The study aims to gather evidence on whether TPS can provide significant benefits for individuals with Parkinson's Disease.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 to 90 with a confirmed diagnosis of Parkinson's Disease in stages 2 to 4.

Not a fit: Patients with Parkinson's-plus syndromes or those who have undergone certain brain surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to improved management of Parkinson's Disease symptoms and enhance the quality of life for patients.

How similar studies have performed: Previous research has shown promise for TPS in treating Alzheimer's disease, suggesting potential applicability for Parkinson's, though this specific approach is still being explored.

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.

Where this trial is running

Cambridge, Massachusetts

• Spaulding Rehabilitation Hospital — Cambridge, Massachusetts, United States (RECRUITING)

Study contacts

• Study coordinator: Felipe Fregni, MD, PhD, MPH

Conditions: Parkinson