Effects of Transcranial Pulse Stimulation in Parkinson's Disease

December 3, 2025 updated by: Felipe Fregni, MD, PhD, MPH, Spaulding Rehabilitation Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • Spaulding Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosis of "probable" or "possible" 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 PD 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, 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 MGB 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TPS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: Baseline, post intervention (from enrollment to the end of intervention at 4 weeks), and follow up (after 4 weeks from the last day of intervention).)
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 score can be up to 232.
Baseline, post intervention (from enrollment to the end of intervention at 4 weeks), and follow up (after 4 weeks from the last day of intervention).)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spaulding Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2024

Primary Completion (Actual)

June 27, 2025

Study Completion (Actual)

July 30, 2025

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024P002627

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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