TUS to Disrupt Pathological Oscillations

NCT06932185 | Enrolling By Invitation

• 1 other identifier: 322261
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• LFP modulation

  Electrical activity recorded from indwelling Deep Brain Stimulation electrodes

  Change from baseline during ultrasound

Study Arms (3)

TUS active

EXPERIMENTAL

Other: Transcranial Focussed Ultrasound - Active

TUS sham

SHAM COMPARATOR

Other: Transcranial Focussed Ultrasound - Sham

TUS Active Control

ACTIVE COMPARATOR

Other: Transcranial Focussed Ultrasound - Active control

Interventions

Transcranial Focussed Ultrasound - Active OTHER

Transcranial focussed ultrasound to target site

TUS active

Transcranial Focussed Ultrasound - Sham OTHER

Transcranial focussed ultrasound off

TUS sham

Transcranial Focussed Ultrasound - Active control OTHER

Transcranial focussed ultrasound on to control

TUS Active Control

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford

Oxford, OX39DU, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 17, 2025
• Study Start: February 28, 2024
• Primary Completion (Estimated): June 9, 2028
• Study Completion (Estimated): July 9, 2028
• Last Updated: April 17, 2025

Record last verified: 2024-12

Locations

GB (1)