An interventional study of Transcranial Pulse Stimulation (TPS) in Parkinson, sponsored by Spaulding Rehabilitation Hospital. Completed at 1 site in United States. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Spaulding Rehabilitation Hospital · Not applicable, Interventional, and Treatment
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.
Spaulding Rehabilitation Hospital is the lead sponsor of 114 studies on the registry; 26 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Transcranial Pulse Stimulation (TPS)
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.
Unified Parkinson's Disease Rating Scale (UPDRS)
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).
Time frame: Baseline and 4 weeks, immediately post-intervention (Visit 12).
| Milestone | Active TPS |
|---|---|
| Started | 14 |
| Completed | 14 |
| Not completed | 0 |
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).
| units on a scale | Active TPS |
|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) | -9.43 ± 5.36 |
Collected over 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active TPS | 0/14 (0%) | 0/14 (0%) | 2/14 (14.3%) |
| Event | Active TPS |
|---|---|
| Mild pain/pressureSkin and subcutaneous tissue disorders | 2/14 |
Baseline of enrolled participants
| Age, Continuous(years) | Active TPS |
|---|---|
| Mean | 69.36 ± 8.53 |
| Sex: Female, Male(Participants) | Active TPS |
|---|---|
| Female | 4 |
| Male | 10 |
| Ethnicity (NIH/OMB)(Participants) | Active TPS |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 13 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Active TPS |
|---|---|
| United States | 14 |
| Unified Parkinson's Disease Rating Scale (UPDRS)(units on a scale) | Active TPS |
|---|---|
| Mean | 47.79 ± 16.56 |
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Spaulding Rehabilitation Hospital