LIFUS For Neurological Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LIFUS, Sham LIFUS.
- Who it may be relevant to
- Registry conditions: Parkinson's Disease (PD), Essential Tremor, Orthostatic Tremor, Dystonia. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Effects of Low-Intensity Focused Ultrasound Neuromodulation in Patients With Neurological and Psychiatric Disorders
Overview
Low intensity focused ultrasound (LIFUS) has the potential to be used as a means of non-invasive neuro-modulation. To this day, the use of LIFUS is under investigation. Studies in healthy subjects have shown that application of LIFUS to the motor region of the brain can mildly decrease neuron excitability in healthy controls. The purpose of the present study is to evaluate the effects of LIFUS on brain tissue excitability in patients with movement disorders in order to elucidate the therapeutic potential of LIFUS.
Interventions
- Device LIFUS
Low-intensity focused ultrasound neuromodulation delivered to targeted cortical and/or subcortical brain regions to transiently modulate neural activity. LIFUS may be applied alone or in combination with concurrent neurophysiological assessments (e.g., TMS-evoked motor evoked potentials, EEG recordings, or DBS local field potential sensing) depending on the study component. - Device Sham LIFUS
Sham low-intensity focused ultrasound stimulation designed to mimic the sensory and procedural aspects of active LIFUS without delivering therapeutic ultrasound energy. The sham condition serves as a control to maintain blinding of participants and investigators.
Primary outcome measures
- Neurophysiological Effects of Low-Intensity Focused Ultrasound [Time frame: Baseline and post-intervention on Day 1]
- Change in Clinical and Behavioral Function Following LIFUS [Time frame: Baseline and post-intervention on Day 1]
Eligibility criteria
Inclusion criteria
- 18-85 years of age
- Patients diagnosed with neurological disorders, (such as epilepsy, brain tumour, movement disorders) or psychiatric disorders (such as substance abuse disorder)
- Patients undergoing medical or surgical treatment (such as DBS) for neurological disorders
Exclusion criteria
- History of stroke
- Comorbid dementia
- Scored below 22 on the Montreal Cognitive Assessment (MoCA)
- Has an implanted cardiac pacemaker or implantable cardioverter-defibrillator (ICD)
- Presence of metal implanted in body that is contraindicated in TMS/MRI
- Pregnancy
- Major depression/psychiatric disorder that in the opinion of the Investigator will affect patient's understanding of study procedures and willingness to abide by all procedures during the course of the study
- Receiving a psychotropic medication or taking recreational substances that in the opinion of the investigator will significantly affect safety of the protocol
- Major systemic illness or infection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Canada · 1 center
- Toronto Western Hospital, 399 Bathurst St — Toronto
Identifiers
NCT: NCT07417280 · 19-6139