None listed
Conditions
Brief summary
This study evaluates the feasibility and efficacy of focused ultrasound neuromodulation (SUS) for the treatment of agitation in individuals with Alzheimer's disease. The intervention involves the use of the UltraThera system investigational device. The study hypothesis is that SUS can modulate brain activity to reduce the behavioural and psychological symptoms of dementia by applying low-intensity ultrasound waves to specific areas of the brain involved in emotion and behaviour.
Interventions
The UltraThera device (second-generation) is a non-invasive neuromodulation system. It functions by delivering precise, low-intensity ultrasound waves to targeted brain regions. The device is applied to the participant's scalp and utilises image-guided navigation to ensure the acoustic energy is focused accurately on individualised neuroanatomical coordinates. The ultrasound parameters remain constant across all participants receiving verum treatments. Settings are equivalent to those used in ou
The UltraThera device (second-generation) is a non-invasive neuromodulation system. It functions by delivering precise, low-intensity ultrasound waves to targeted brain regions. The device is applied to the participant's scalp and utilises image-guided navigation to ensure the acoustic energy is focused accurately on individualised neuroanatomical coordinates. The ultrasound parameters remain constant across all participants receiving verum treatments. Settings are equivalent to those used in our previous study e.g <500 kHz centre frequency, peak negative pressure in free field 1.95 MPa, pulse repetition frequency 10 Hz, pulse length 10 ms, individual sonication duration 6 s depth of treatment 55-85mm, acoustic radiation force index <0.175, ISPPA <22 W/cm2). Treatment depth will be individualised based on MRI. Treatment is administered by clinical investigators. These personnel are specifically trained in the operation of the UltraThera system and the application of image-guided navigation protocols. Delivery is performed face-to-face in an individualised session. The investigator uses the participant’s pre-acquired MRI data to navigate the ultrasound beam to the specific region of interest and pre-specified treatment depth using an MRI of the patient's brain taken before the treatment day. The intervention consists of four treatment sessions. These are delivered once per week for four consecutive weeks. Each session lasts approximately 30 minutes. Once inducted into the study, participants will undergo baseline assessments including cognitive and behavioural tests and an MRI if they don’t already have a suitable MRI for targeting. All screening, testing, and treatments are conducted within a clinical research facility or hospital. To promote adherence to the intervention and track participant engagement, the following strategies are employed: Actigraphy Monitoring: Participants are required to wear a wrist-worn GeneActiv actigraphy device throughout the trial period. This provides objective data regarding activity patterns and sleep-wake cycles. Clinical Assessments: Feasibility and adherence are monitored via regular assessments and session attendance is logged by the clinical investigator to confirm that the four-week protocol is followed without significant deviation.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
o Age 50 years or older. o Probable Alzheimer’s disease diagnosis (NINCDS-ADRDA criteria). o MMSE score between 5 and 25. o Clinically significant agitation (NPI Agitation/Aggression) present for at least 2 weeks. o Stable dose of anti-dementia or psychoactive medications for at least 8 weeks. o Presence of a live-in caregiver or informant spending at least 15 hours per week with the participant. o Participant’s legally designated representative must be able to freely give written informed consent; additionally, if, in the clinical judgment of the Principal Investigator, the participant themselves has the mental capacity to provide consent, they will also provide consent. o Ability to comply with study regimen and provide contact phone number. o Ability to communicate during procedures.
Exclusion criteria
o Contraindications to MRI (e.g., metallic implants, claustrophobia) if an MRI is required. o Any major medical illness (unstable cardiovascular, pulmonary, or renal disease) that could interfere with the study. o Scalp or skull abnormalities o History of major psychiatric disorders o History of drug or alcohol abuse o Participation in other clinical trials within 90 days from the screening date o An inability to communicate during a treatment procedure o A body weight exceeding 200 kg o Pregnancy or breastfeeding.
Outcome results
None listed