Transcranial Pulse Stimulation for Parkinson's Disease

Overseen By Felipe Fregni, MD, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

Must be taking: PD medications

Disqualifiers: Schizophrenia, Bipolar, Alcohol/drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

14 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether Transcranial Pulse Stimulation (TPS) can benefit people with Parkinson's disease. Researchers aim to determine if TPS can improve symptoms such as movement issues, mood, fatigue, voice quality, and problems with smell and taste. They are also assessing the safety and practicality of TPS. Individuals with a confirmed Parkinson's diagnosis who have been on stable medication for at least 30 days may qualify for this study. As an unphased trial, this study provides a unique opportunity for participants to contribute to groundbreaking research that could lead to new treatment options for Parkinson's disease.

Will I have to stop taking my current medications?

The trial requires that participants have been taking stable medications for Parkinson's disease for at least 30 days, so you will not need to stop your current medications.

What prior data suggests that Transcranial Pulse Stimulation is safe for Parkinson's Disease?

Research has shown that Transcranial Pulse Stimulation (TPS) is generally safe for people with Parkinson's disease. In one study, participants reported no harmful side effects from TPS. Another study found that after 10 sessions, TPS not only proved safe but also improved movement in patients with Parkinson's. This non-invasive treatment does not involve surgery or entering the body, making it a low-risk option. While more research is needed, current findings suggest TPS is well-tolerated and could benefit those with Parkinson's. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Pulse Stimulation (TPS) is unique because it offers a non-invasive approach to treating Parkinson's disease, unlike the standard medications that typically involve oral drugs like levodopa. TPS uses focused ultrasound waves to stimulate specific areas of the brain, potentially improving motor symptoms without the side effects often associated with traditional drug therapies. Researchers are excited about TPS because it could offer a new way to manage symptoms with fewer complications and a different mechanism of action, providing hope for improved quality of life for patients with Parkinson's.

What evidence suggests that Transcranial Pulse Stimulation might be an effective treatment for Parkinson's?

Research shows that Transcranial Pulse Stimulation (TPS), the treatment under study in this trial, might help alleviate Parkinson's disease symptoms. Studies have found that TPS can reduce tremors for at least 24 hours after a single session. Research in Alzheimer's disease suggests it might also enhance thinking and mood. TPS targets brain areas that control movement and mood, potentially leading to improvements in these functions. These early findings suggest TPS could benefit people with Parkinson's. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's disease who experience symptoms like movement issues, cognitive decline, mood changes, fatigue, walking difficulties, voice problems, and altered smell and taste. The exact eligibility criteria are not provided.

Inclusion Criteria

I am between 40 and 90 years old.

I have been on the same Parkinson's disease medication for at least 30 days.

Diagnosis of 'probable' or 'possible' PD, as defined by the current clinical criteria or confirmed by a co-investigator neurologist or medical records

Exclusion Criteria

Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality

Unstable medical conditions

My condition may not be typical Parkinson's disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Transcranial Pulse Stimulation (TPS) to assess its effects on Parkinson's disease symptoms

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Pulse Stimulation (TPS)

Trial Overview The study investigates Transcranial Pulse Stimulation (TPS) to see if it can improve a range of Parkinson's symptoms from motor function to sensory experiences. It aims to assess the safety and effectiveness of TPS in enhancing life quality for patients.

How Is the Trial Designed?

Group I: TPS Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

Published Research Related to This Trial

Transcranial pulse stimulation (TPS) has shown significant improvements in cognitive performance and reductions in depressive symptoms among 99 Alzheimer's disease patients, as evidenced by various cognitive assessment scales.

TPS appears to be a safe treatment option, with only mild and reversible side effects reported, and no serious adverse events observed, suggesting its potential as an adjunct therapy for Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial pulse stimulation in Alzheimer's disease. Chen, X., You, J., Ma, H., et al.[2023]

Transcranial noninvasive brain stimulation techniques, including rTMS and tDCS, show promising potential for treating nonmotor symptoms of Parkinson's disease, particularly depressive symptoms and cognitive dysfunctions.

Current studies are preliminary, highlighting the need for more rigorously controlled trials with larger, well-defined participant groups to better assess the efficacy and safety of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Brain Stimulation and Implications for Nonmotor Symptoms in Parkinson's Disease. Rektorová, I., Anderková, Ľ.[2018]

Transcranial Pulse Stimulation (TPS) was found to significantly improve motor symptoms in 20 Parkinson's disease patients, with a notable reduction in Unified Parkinson's Disease Rating Scale part III (UPDRS-III) scores after ten treatment sessions.

The treatment was deemed safe, as no major side effects were reported during the intervention, suggesting TPS could be a beneficial add-on therapy for patients already receiving standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel ultrasound neuromodulation therapy with transcranial pulse stimulation (TPS) in Parkinson's disease: a first retrospective analysis. Osou, S., Radjenovic, S., Bender, L., et al.[2023]

Transcranial pulse stimulation (TPS) appears to be a safe and promising add-on therapy for Alzheimer's disease, with only rare and transient side effects reported in 4% of sessions among 11 patients studied.

Patients showed significant improvements in cognitive function as measured by the ADAS and ADAS Cog tests, along with self-reported reductions in symptom severity and depressive symptoms, suggesting TPS may benefit both cognitive and emotional aspects of Alzheimer's.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective real-world pilot data on transcranial pulse stimulation in mild to severe Alzheimer's patients. Cont, C., Stute, N., Galli, A., et al.[2022]

Transcranial pulse stimulation (TPS) showed potential cognitive benefits in Alzheimer's patients, particularly in improving cognition and language, but it negatively affected visuo-constructive functions, highlighting a specific functional impact of the treatment.

In a study of 18 Alzheimer's patients, it was found that important nodes in the visuo-constructive network were not stimulated, leading to decreased network efficiency and correlating with poorer visuo-constructive test scores, suggesting that TPS may need to be tailored to target specific brain areas for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Specificity of TPS Brain Stimulation Effects in Patients with Alzheimer's Disease: A Follow-up fMRI Analysis. Dörl, G., Matt, E., Beisteiner, R.[2022]

A review of 84 single pulse and paired-pulse TMS studies with 1091 Parkinson's disease patients, and 77 repetitive TMS studies with 1137 patients, found a very low risk of adverse events, with no seizures reported.

The overall risk of adverse events from rTMS was 0.040 per patient, with common side effects being mild and transient, such as headaches and scalp pain, indicating that TMS is generally safe for Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial magnetic stimulation in Parkinson's disease: a review of the literature. Vonloh, M., Chen, R., Kluger, B.[2021]

Noninvasive brain stimulation techniques, like high-frequency rTMS and anodal tDCS, can enhance cortical activity in Parkinson's disease patients, potentially improving both motor and nonmotor symptoms.

The effectiveness of these techniques depends on using optimal stimulation parameters, and further clinical studies are needed to explore their combined effects with medication and neurorehabilitation therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive neuromodulation in Parkinson's disease: Neuroplasticity implication and therapeutic perspectives. Cosentino, G., Todisco, M., Blandini, F.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12292182/

Investigating the Effects of Transcranial Pulse Stimulation ... Findings from AD studies suggest that TPS might induce improvements in cognitive impairment and depression symptoms, with potential application ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0006899324006607

Effect of a single session of transcranial pulse stimulation ... TPS on motor cortex decreases PD tremor, for at least 24 h after single-sessions. •. TPS is a new solution that may reduce tremor in PD; further ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06676995

NCT06676995 | Effects of Transcranial Pulse Stimulation in ... The investigators are studying if Transcranial Pulse Stimulation (TPS) can improve various symptoms, including movement problems, thinking abilities, mood, ...

4. medrxiv.org medrxiv.org/content/10.1101/2025.07.07.25330807v1

A Randomized Sham-Controlled Clinical Trial These findings indicate that TPS produces behavioral, neurophysiological, and structural effects within the targeted sensorimotor network.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10896933/

Novel ultrasound neuromodulation therapy with ... TPS is a promising novel brain stimulation technique. The presented results support and extend the understanding of the safety and efficacy ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3653978/

Safety of Transcranial Magnetic Stimulation in Parkinson's ... Risk of adverse events was low in all protocols. spTMS and ppTMS risk per patient for any adverse event was 0.0018 (95% CI: 0.0002 – 0.0066) per patient and no ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11871398/

Clarifying the Specificity of Transcranial Pulse Stimulation ... The safety of TPS in the treatment of Parkinson's disease has been studied, and no adverse events have been observed [#47]. TPS is a low‐intensity ...

8. mdpi.com mdpi.com/2306-5354/12/7/773

Study Protocol: Investigating the Effects of Transcranial ... A recent observational study reported that 10 sessions of TPS therapy were safe in PD subjects and led to improvements in clinical motor function in optimized ...