TUS to Disrupt Pathological Oscillations

April 9, 2025 updated by: University of Oxford

Transcranial Ultrasound to Disrupt Pathological Oscillations in the Brain of People With Parkinson's Disease and Other Neurological Disorders

Scientists and clinicians are interested in measuring and perturbing the signals in the brain - both to better understand normal operation and explore new therapy options for disease. One example of a signal is a "brainwave," also called a neural oscillation, which is a periodic oscillation of the electrical signals in the brain and which are linked to both normal and abnormal brain function.

When circuits in the brain are not working properly, investigators can see changes in the characteristics of these oscillations. Many neurological conditions produce changes in brainwaves. For example, in patients with Parkinson's disease, oscillations in the "beta band" (approximately 15Hz) are observed to be more prominent. In another example, investigators see similar large oscillations in the presence of a seizure in people with epilepsy. Disrupting these abnormal oscillations can treat some of the symptoms of disease. One example of this is found in Parkinson's disease, where surgeons can implant electrodes deep in the brain and electrically stimulate cells by a process called deep brain stimulation (DBS). With DBS, it is possible to suppress these beta oscillations and improve symptoms. However, DBS is a highly invasive procedure that includes the need for a burr hole in the skull, placement of the electrode in the brain, and insertion of a "pacemaker" in the chest with wires tunnelled through the neck. The investigators propose to use ultrasound to modify pathological brainwaves non-invasively.

While the proof-of-concept is in Parkinson's disease, the potential impact is much broader - if successful, the investigators will provide a non-invasive paradigm for probing the brain and exploring novel treatments for neurological conditions, such as pain and cognitive disorders.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Transcranial Ultrasound Stimulation (TUS):

TUS will be applied using a commercially available transcranial ultrasound transducer and neuronavigation system that allows for targeting of specific brain regions. TUS targeting will be based on participant specific MRI and CT scans that take place as part of routine pre-operative planning before DBS implantation. TUS will then be applied during cognitive and motor tasks as described below.

Clinical assessments:

During each step of the study visit, during TUS to each target, clinical assessments will be made for each participant. These will be specific to the disease of interest and will be completed by a clinician. They will be filmed so that they can be assessed by blinded assessors after the study visit and allow for blinded quantification of TUS on clinical symptoms. A member of the research team will film assessments whilst a clinician completes them, and they will later scramble the video files to allow blinded assessment at a later date.

Cognitive tasks include a dot direction discrimination task and for pain participants will include quantitative sensory testing. Motor tasks will include a stop signal task.

During the TUS, Sham and Alternative brain target TUS, measurements will include EEG, Local Field Potentials (LFPs) recorded from the DBS electrodes, ECG.

Study Type

Interventional

Enrollment (Estimated)

30

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

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:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Implanted Medtronic Percept or equivalent DBS system (one that can measure LFPs) or externalised depth electrodes as part of routine care
  • Participant willing and able to tolerate transcranial ultrasound stimulation.
  • Stable therapy with no drug changes in past 6 weeks
  • Measurable beta peak on screening

Exclusion Criteria:

  • Patients with extreme language barrier that cannot understand the purpose or instructions of the study despite the use of an interpreter.
  • Patients with implanted electrodes without telemetric capacity.
  • Co-morbid neurological disorder that may confound results, e.g. second motor impairment.
  • Fever at time of study visit (>38 degrees Celsius)

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TUS active
Other: Transcranial Focussed Ultrasound - Active
Transcranial focussed ultrasound to target site
Sham Comparator: TUS sham
Other: Transcranial Focussed Ultrasound - Sham
Transcranial focussed ultrasound off
Active Comparator: TUS Active Control
Other: Transcranial Focussed Ultrasound - Active control
Transcranial focussed ultrasound on to control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LFP modulation
Time Frame: Change from baseline during ultrasound
Electrical activity recorded from indwelling Deep Brain Stimulation electrodes
Change from baseline during ultrasound

Collaborators and Investigators

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

Sponsor

University of Oxford

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)

February 28, 2024

Primary Completion (Estimated)

June 9, 2028

Study Completion (Estimated)

July 9, 2028

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 322261

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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