Parkinson DiseaseNCT06932185
TUS to Disrupt Pathological Oscillations
A study testing Transcranial Focussed Ultrasound - Active in people with Parkinson Disease, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Transcranial Focussed Ultrasound - Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2024to 9 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Transcranial Focussed Ultrasound - Active, Transcranial Focussed Ultrasound - Sham, Transcranial Focussed Ultrasound - Active control
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Focussed Ultrasound - ActiveOther
Transcranial focussed ultrasound to target site
Transcranial Focussed Ultrasound - ShamOther
Transcranial focussed ultrasound off
Transcranial Focussed Ultrasound - Active controlOther
Transcranial focussed ultrasound on to control
| Study group | Role | What they receive |
|---|---|---|
| TUS active | Experimental | Not described Receives: Other: Transcranial Focussed Ultrasound - Active |
| TUS sham | Sham comparator | Not described Receives: Other: Transcranial Focussed Ultrasound - Sham |
| TUS Active Control | Active comparator | Not described Receives: Other: Transcranial Focussed Ultrasound - Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
LFP modulation
Electrical activity recorded from indwelling Deep Brain Stimulation electrodes
Measured: Change from baseline during ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start28 Feb 2024
- Primary completion9 Jun 2028 (estimated)
- Study completion9 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932185
- Sponsor's protocol ID
- 322261
- Status last verified
- Dec 2024
- First submitted
- 27 Mar 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eraifej J, Toth J, Hanemaaijer J, He S, Cheng X, Divanbeighi Zand AP, Stewart ME, FitzGerald JJ, Butler CR, Denison T, Green AL, Cleveland RO. Suppression of pathological oscillations with transcranial focused ultrasound in Parkinson's disease. Nat Commun. 2026 Mar 25;17(1):4471. doi: 10.1038/s41467-026-70714-7.
PubMed 41876482
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Ultrasound to Disrupt Pathological Oscillations in the Brain of People With Parkinson's Disease and Other Neurological Disorders
- ClinicalTrials.gov ID
- NCT06932185
- Acronym / sponsor ID
- 322261
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 9 Jun 2028 (estimated)
- Study completion
- 9 Jul 2028 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Focussed Ultrasound - ActiveTranscranial focussed ultrasound to target site | Other | TUS active |
| Transcranial Focussed Ultrasound - ShamTranscranial focussed ultrasound off | Other | TUS sham |
| Transcranial Focussed Ultrasound - Active controlTranscranial focussed ultrasound on to control | Other | TUS Active Control |
Primary outcome
LFP modulation
Time frame: Change from baseline during ultrasound
Electrical activity recorded from indwelling Deep Brain Stimulation electrodes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Derived from this study: PubMed 41876482Eraifej J, Toth J, Hanemaaijer J, He S, Cheng X, Divanbeighi Zand AP, Stewart ME, FitzGerald JJ, Butler CR, Denison T, Green AL, Cleveland RO. Suppression of pathological oscillations with transcranial focused ultrasound in Parkinson's disease. Nat Commun. 2026 Mar 25;17(1):4471. doi: 10.1038/s41467-026-70714-7.
- Individual participant dataSharing planned: Undecided
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PARKINSON DISEASE (Disorder)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Focussed Ultrasound - Active in people with Parkinson Disease, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LFP modulation (time frame: Change from baseline during ultrasound). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06932185, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.