ParkinsonNCT06676995

Effects of Transcranial Pulse Stimulation in Parkinson's Disease

A study testing Transcranial Pulse Stimulation (TPS) in people with Parkinson, run by Spaulding Rehabilitation Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 90 years
Conditions the study is for: Parkinson
What is being tested?: Transcranial Pulse Stimulation (TPS)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 31 Dec 2024to 30 Jul 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
Age from 40 to 90 years old.
Disease stages 2 to 4 based on the UPDRS scale subdomain V (or Hoehn and Yahr scale).
Taking stable medications for Parkinson's Disease for at least 30 days.

Who cannot join

Features suggestive of other causes of parkinsonism/Parkinson's-plus syndromes.
History of deep brain stimulation, brain ablation surgeries, or malignant mass brain lesions.
History of schizophrenia, bipolar illness, or alcohol/drug abuse within the past six months.
Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality.
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).
Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, uncompensated pulmonary disease, or chronic obstructive pulmonary disease).

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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).
Pregnancy.
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.
Bed- or wheelchair-bound patients.

Trial locations and contacts

1 site in 1 country.

United States1 site

Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, 02138

Other trials in United States

About this study

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

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.

Conditions: Parkinson
Being tested: Transcranial Pulse Stimulation (TPS)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial Pulse Stimulation (TPS)Device
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.

Study groups in NCT06676995
Study group	Role	What they receive
TPS	Experimental	Not described Receives: Device: Transcranial Pulse Stimulation (TPS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Baseline and 4 weeks, immediately post-intervention (Visit 12).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Dec 202430 Jul 2025

First posted6 Nov 2024
Study start31 Dec 2024
Primary completion27 Jun 2025
Study completion30 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for ParkinsonStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06676995
Sponsor's protocol ID: 2024P002627
Status last verified: Aug 2026
First submitted: 4 Nov 2024
Last updated: 10 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Shinzato GT, Assone T, Sandler PC, Pacheco-Barrios K, Fregni F, Radanovic M, Forlenza OV, Battistella LR. Non-invasive sound wave brain stimulation with Transcranial Pulse Stimulation (TPS) improves neuropsychiatric symptoms in Alzheimer's disease. Brain Stimul. 2024 Mar-Apr;17(2):413-415. doi: 10.1016/j.brs.2024.03.007. Epub 2024 Mar 20.
PubMed 38513821
Fong TKH, Cheung T, Ngan STJ, Tong K, Lui WYV, Chan WC, Wong CSM, Cheng CPW. Transcranial pulse stimulation in the treatment of mild neurocognitive disorders. Ann Clin Transl Neurol. 2023 Oct;10(10):1885-1890. doi: 10.1002/acn3.51882. Epub 2023 Aug 21.
PubMed 37607114
Osou S, Radjenovic S, Bender L, Gaal M, Zettl A, Dorl G, Matt E, Beisteiner R. Novel ultrasound neuromodulation therapy with transcranial pulse stimulation (TPS) in Parkinson's disease: a first retrospective analysis. J Neurol. 2024 Mar;271(3):1462-1468. doi: 10.1007/s00415-023-12114-1. Epub 2023 Nov 30.
PubMed 38032371

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Parkinson's Disease: Overall Symptoms Improvement With Transcranial Pulse Stimulation (TPS)
ClinicalTrials.gov ID: NCT06676995
Acronym / sponsor ID: 2024P002627
Conditions: Parkinson
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Spaulding Rehabilitation HospitalUniversity, hospital or other
Study start: 31 Dec 2024 (actual)
Primary completion: 27 Jun 2025 (actual)
Study completion: 30 Jul 2025 (actual)
First posted: 6 Nov 2024 (actual)
Results: Posted 10 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TPS	Experimental	Device: Transcranial Pulse Stimulation (TPS)

Who may qualify

Ages: 40 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.
Age from 40 to 90 years old.
Disease stages 2 to 4 based on the UPDRS scale subdomain V (or Hoehn and Yahr scale).
Taking stable medications for Parkinson's Disease for at least 30 days.

Key exclusion criteria (10 listed)

Features suggestive of other causes of parkinsonism/Parkinson's-plus syndromes.
History of deep brain stimulation, brain ablation surgeries, or malignant mass brain lesions.
History of schizophrenia, bipolar illness, or alcohol/drug abuse within the past six months.
Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality.
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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	TPS

Primary outcome

Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: 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).

Results and safety

Results posted to the registry on 10 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active TPS	14	14

Primary outcome: Unified Parkinson's Disease Rating Scale (UPDRS)

Time frame: Baseline and 4 weeks, immediately post-intervention (Visit 12).. Mean (Standard Deviation). Unit: units on a scale

Measure	Active TPS n = 14
Value	-9.43 (5.36)

Adverse events

Time frame: 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active TPS	0 of 14 (0%)	2 of 14 (14.3%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 38513821Shinzato GT, Assone T, Sandler PC, Pacheco-Barrios K, Fregni F, Radanovic M, Forlenza OV, Battistella LR. Non-invasive sound wave brain stimulation with Transcranial Pulse Stimulation (TPS) improves neuropsychiatric symptoms in Alzheimer's disease. Brain Stimul. 2024 Mar-Apr;17(2):413-415. doi: 10.1016/j.brs.2024.03.007. Epub 2024 Mar 20.
Background: PubMed 37607114Fong TKH, Cheung T, Ngan STJ, Tong K, Lui WYV, Chan WC, Wong CSM, Cheng CPW. Transcranial pulse stimulation in the treatment of mild neurocognitive disorders. Ann Clin Transl Neurol. 2023 Oct;10(10):1885-1890. doi: 10.1002/acn3.51882. Epub 2023 Aug 21.
Background: PubMed 38032371Osou S, Radjenovic S, Bender L, Gaal M, Zettl A, Dorl G, Matt E, Beisteiner R. Novel ultrasound neuromodulation therapy with transcranial pulse stimulation (TPS) in Parkinson's disease: a first retrospective analysis. J Neurol. 2024 Mar;271(3):1462-1468. doi: 10.1007/s00415-023-12114-1. Epub 2023 Nov 30.

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Enrolling by invitationObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Pulse Stimulation (TPS) in people with Parkinson, run by Spaulding Rehabilitation Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unified Parkinson's Disease Rating Scale (UPDRS) (time frame: Baseline and 4 weeks, immediately post-intervention (Visit 12).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06676995, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.