Transcranial Focused Ultrasound for Neurocognitive Disorder

KC
Overseen ByKevin Caulfield, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new noninvasive treatment called transcranial focused ultrasound (tFUS), aimed at improving memory in people with mild neurocognitive disorder (mNCD). The study will test tFUS on different parts of the brain to determine which area responds best. It seeks participants aged 50-85 who have been diagnosed with mNCD in the past two years and have a partner or caregiver they see at least weekly. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

You may need to stop taking daily or weekly anticholinergic or sedative medications. However, you can continue using cholinesterase inhibitors, NMDA receptor antagonists, and antidepressants if you have been on a stable dose for at least 4 weeks before joining the trial.

What prior data suggests that transcranial focused ultrasound is safe for improving memory in neurocognitive disorders?

Research has shown that transcranial focused ultrasound (tFUS) is generally safe and well-tolerated. In studies using tFUS to stimulate the brain, most participants did not experience serious side effects. Some reported mild symptoms like slight headaches or dizziness, but these were temporary and not severe. Experts have developed guidelines to ensure safe use and minimize risks. As tFUS continues to be tested for this specific purpose, more information is needed to fully understand its safety. However, current results are promising regarding its overall safety for participants.12345

Why are researchers excited about this trial's treatment?

Researchers are excited about transcranial focused ultrasound for neurocognitive disorders because it offers a non-invasive approach that targets specific brain areas without the need for medication. Unlike traditional treatments such as medications or cognitive therapies, which can take weeks to show effects, focused ultrasound could potentially deliver faster results by directly stimulating brain regions involved in cognitive functions. This method also minimizes side effects typically associated with pharmaceuticals, making it a promising alternative for patients. By precisely directing ultrasound waves to different brain locations, researchers hope to better understand and improve cognitive processes in affected individuals.

What evidence suggests that transcranial focused ultrasound could be an effective treatment for neurocognitive disorder?

Research has shown that transcranial focused ultrasound (tFUS) could aid memory and thinking problems, such as those seen in dementia. One study found that 62.5% of patients improved significantly in at least one cognitive area. Another study with Alzheimer's patients showed that tFUS enhanced their thinking skills after just two weeks of treatment. This treatment also maintained their cognitive abilities for up to a year without causing harmful side effects. In this trial, participants will receive tFUS targeted to different brain locations to evaluate its effects on neurocognitive disorders. These findings suggest that tFUS might improve memory and thinking in individuals with brain-related disorders.678910

Who Is on the Research Team?

KC

Kevin Caulfield, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults aged 50-85 who speak English as their first language and have the ability to consent. It's aimed at those without a diagnosis of mild neurocognitive disorder (mNCD) or dementia, focusing on healthy aging individuals.

Inclusion Criteria

I am a healthy older adult.
I am between 50 and 85 years old.
I have not been diagnosed with major neurocognitive disorder or dementia.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial focused ultrasound (tFUS) to the hippocampus to examine effects on memory

1 hour
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Transcranial Focused Ultrasound
Trial Overview The study is testing transcranial focused ultrasound (tFUS), a noninvasive brain stimulation targeting the hippocampus, with the aim of improving memory in both healthy older adults and those with mNCD.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Focused Ultrasound to Location CExperimental Treatment1 Intervention
Group II: Focused Ultrasound to Location BExperimental Treatment1 Intervention
Group III: Focused Ultrasound to Location AExperimental Treatment1 Intervention
Group IV: Focused Ultrasound to Location DPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

National Center of Neuromodulation for Rehabilitation

Collaborator

Trials
12
Recruited
240+

Citations

Focused transcranial ultrasound for treatment of ...Of all, 62.5% of patients demonstrated clinically significant improvement on at least one cognitive measure, suggesting some positive interventional effect.
Ultrasound Neuromodulation With Transcranial Pulse ...Findings In a randomized clinical trial in 60 patients with AD receiving state-of-the-art therapy, 2 weeks of verum TPS significantly improved ...
Safety and efficacy of transcranial ultrasound stimulation ...AD patients treated with TUS exhibited cognitive stabilization for up to one year after the start of treatment. •. TUS did not cause clinical ...
A panoramic review of transcranial focused ultrasound ...The effects and mechanisms of transcranial ultrasound stimulation combined with cognitive rehabilitation on post-stroke cognitive impairment.
Transcranial Focused Ultrasound: A New Frontier for Non- ...Research studies using tFUS have demonstrated its ability to alter neuronal activity in several brain regions, including the somatosensory ...
Safety Review and Perspectives of Transcranial Focused ...This review aims to provide safety information and perspectives of tFUS brain stimulation. First, the acoustic parameters most relevant to ...
ITRUSST Consensus on Biophysical Safety for ...Protocols exceeding these levels are not necessarily unsafe or significant risk. Further data is needed to establish the threshold for ...
A retrospective qualitative report of symptoms and safety ...A retrospective qualitative report of symptoms and safety from transcranial focused ultrasound for neuromodulation in humans. Wynn Legon ...
Safety Review and Perspectives of Transcranial Focused ...This review aims to provide safety information and perspectives of tFUS brain stimulation. First, the acoustic parameters most relevant to ...
Study Details | NCT05792020 | Safety, Parameterization ...All participants will receive three sessions of Focused Ultrasound Stimulation to their motor hotspot. This stimulation cycle will operate at a 50% duty cycle.
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