Parkinson
Conditions
Brief summary
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.
Interventions
Transcranial Pulse Stimulation (TPS) is a non invasive brain stimulation technology that applies repetitive single high-pressure ultrashort shockwave pulses within the ultrasound frequency range to stimulate the brain. Subjects will receive 12 TPS sessions conducted three times weekly, for about 40 to 50 minutes/day, over four consecutive weeks.
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 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 Parkinson's Disease 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, central nervous system (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 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). 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) | Baseline and 4 weeks, immediately post-intervention (Visit 12). | Unified Parkinson's Disease Rating Scale (UPDRS) evaluates the motor function, non-motor symptoms (mentation, behavior, and mood), activities of daily living, and complications of therapy. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total UPDRS score is obtained by summing Parts I-IV, with a total score ranging from 0 to 199. Lower scores indicate less severe Parkinson's disease and represent a better outcome; higher scores indicate greater disease severity and represent a worse outcome. The outcome measure represents the change from Baseline to 4 weeks, immediately post-intervention (Visit 12). |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 69.36 years STANDARD_DEVIATION 8.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 10 Participants |
| Unified Parkinson's Disease Rating Scale (UPDRS) | 47.79 units on a scale STANDARD_DEVIATION 16.56 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 2 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
None listed