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?

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.

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.

Is Transcranial Pulse Stimulation (TPS) safe for humans?

Transcranial Pulse Stimulation (TPS) is a new non-invasive treatment that has been studied for conditions like Parkinson's and Alzheimer's. Initial studies suggest it is generally safe, but more research is needed to fully understand any potential risks. ^{1 2 3 4 5}

How is Transcranial Pulse Stimulation (TPS) different from other treatments for Parkinson's disease?

Transcranial Pulse Stimulation (TPS) is unique because it uses focused ultrasound pulses to stimulate the brain in a targeted way, which is different from other non-invasive brain stimulation techniques like magnetic or electrical stimulation. This novel approach has shown potential in improving brain function by increasing connectivity and inducing neuroplasticity (the brain's ability to reorganize itself), which could be beneficial for Parkinson's disease. ^{1 2 3 5 6}

What data supports the effectiveness of the treatment Transcranial Pulse Stimulation (TPS) for Parkinson's Disease?

Research on Transcranial Pulse Stimulation (TPS) shows it can increase brain activity and connectivity, which has been beneficial in treating Alzheimer's disease. Similar noninvasive brain stimulation techniques have shown promise in improving symptoms in Parkinson's disease, suggesting TPS might also be effective. ^{1 2 3 6 7}

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

My condition may not be typical Parkinson's disease.

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

Unstable medical conditions

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 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]

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]

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) 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 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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Noninvasive Brain Stimulation and Implications for Nonmotor Symptoms in Parkinson's Disease. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Noninvasive neuromodulation in Parkinson's disease: Neuroplasticity implication and therapeutic perspectives. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Novel ultrasound neuromodulation therapy with transcranial pulse stimulation (TPS) in Parkinson's disease: a first retrospective analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Transcranial pulse stimulation in Alzheimer's disease. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Functional Specificity of TPS Brain Stimulation Effects in Patients with Alzheimer's Disease: A Follow-up fMRI Analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety of transcranial magnetic stimulation in Parkinson's disease: a review of the literature. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Retrospective real-world pilot data on transcranial pulse stimulation in mild to severe Alzheimer's patients. [2022]