NCT04250376

The Use of Transcranial Focused Ultrasound for the Treatment of Neurodegenerative Dementias

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Neurological Associates of West Los Angeles · Academic / Other
• Sex: All
• Age: 45 Years – 93 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this open label study is to evaluate longer term tolerability and early efficacy of transcranial ultrasound in the treatment of patients with mild cognitive impairment or dementia.

Detailed description

The present study is designed as an open label study of patients with mild cognitive impairment (MCI) or dementia to evaluate longer term tolerability and early efficacy of transcranial ultrasound treatment. Baseline and outcome measures in this study utilize validated tests that are appropriate for repeated measures which are not affected by practice effects. For patients with amnestic predominant cognitive change, the target will be the mesial temporal lobe through a trans temporal scalp window. Targeting will include reference to scalp fiducials based on the obtained MRI and Transcranial Doppler (TCD) waveform confirmation will be obtained because of the ability of TCD to record Doppler signal from the posterior cerebral artery that runs medial to the mesial temporal lobe. On the day of the ultrasound appointment, patients will undergo ten to thirty minutes of transcranial ultrasound treatment. The sonification device will be aimed at the hippocampus or the putamen and substantia nigra, depending on the predetermined condition. Targeting will include reference to scalp fiducials based on the obtained MRI; confirmation of target accuracy will either be obtained by Doppler waveform confirmation or optical tracking technology which co-registers patient neuroimaging with real space. Patients will undergo 8 total sessions of focused ultrasound. Patients will be evaluated at baseline and upon final ultrasound treatment using the same measures obtained upon entry. Safety and any adverse events will be monitored closely.

Conditions

• Mild Cognitive Impairment
• Mild Dementia
• Parkinson Disease
• Alzheimer Disease

Interventions

Type	Name	Description
DEVICE	Focused Transcranial Ultrasound	The FDA has determined the power intensity limits that are safe for clinical use; the proposed equipment works within these parameters. Furthermore, monitoring sessions up to one hour as proposed in this study are routinely used in patients even with acute brain injury at 2 megaHertz without any reports of complications induced by the ultrasound device. No brain heating, cavitation or bleeding has been identified with the proposed equipment and protocol. For each individual safety can be followed by performing a selective mental status exam at each session completion (for example for hippocampal targets, there will be a delayed recall memory test).

Timeline

• Start date: 2017-11-27
• Primary completion: 2024-12-01
• Completion: 2025-01-01
• First posted: 2020-01-31
• Last updated: 2023-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study