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Enrolling by Invitation

NCT Number: NCT06932185

TUS to Disrupt Pathological Oscillations

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oxford

Oxford, OX39DU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transcranial Focussed Ultrasound - Active

Other

Transcranial focussed ultrasound to target site

Transcranial Focussed Ultrasound - Sham

Other

Transcranial focussed ultrasound off

Transcranial Focussed Ultrasound - Active control

Other

Transcranial focussed ultrasound on to control

Primary outcomes

  1. LFP modulation

    Time frame: Change from baseline during ultrasound

    Electrical activity recorded from indwelling Deep Brain Stimulation electrodes

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 17, 2025
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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