Effects of Transcranial Pulse Stimulation in Parkinson's Disease

NCT06676995 | Completed Results FDA Device

• 1 other identifier: 2024P002627
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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).

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

Study Arms (1)

TPS

EXPERIMENTAL

Device: Transcranial Pulse Stimulation (TPS)

Interventions

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.

TPS

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (3)

• 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.

  PMID: 38513821 BACKGROUND

• 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.

  PMID: 37607114 BACKGROUND

• 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.

  PMID: 38032371 BACKGROUND

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Felipe Fregni
• Organization: Spaulding Rehabilitation Hospital, Inc.

Fregni.Felipe@mgh.harvard.edu

6179526158

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Neuromodulation Center, Professor of Rehabilitation

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: December 31, 2024
• Primary Completion: June 27, 2025
• Study Completion: July 30, 2025
• Last Updated: August 10, 2026
• Results First Posted: August 10, 2026

Record last verified: 2026-08

Locations

US (1)