NCT03347084: LIFUP

Deep Brain Stimulation with LIFUP for Mild Cognitive Impairment and Mild Alzheimer's Disease

Completed NA Last updated 5 September 2024

What this trial tests

NA trial testing Excitation in Brain Imaging in 2 participants. Completed in 1 October 2023.

Timeline

10 November 2018

Primary endpoint
31 March 2023

1 October 2023

Quick facts

Lead sponsor	University of California, Los Angeles
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	device feasibility
Enrollment	2
Start date	10 November 2018
Primary completion	31 March 2023
Estimated completion	1 October 2023
Sites	1 location across United States

Drugs / interventions tested

• Excitation
• Inhibition

Conditions studied

• Brain Imaging — all drugs for Brain Imaging →
• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• Alzheimer Disease — all drugs for Alzheimer Disease →
• Deep Brain Stimulation — all drugs for Deep Brain Stimulation →

Sponsor

University of California, Los Angeles

Who can join

55 and older, any sex, with Brain Imaging or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the proposed study is to determine the feasibility of brief brain stimulation, using a device called Low Intensity Focused Ultrasound Pulsation (LIFUP), for persons with mild cognitive impairment (MCI) or mild (early-stage) Alzheimer's disease (AD). As a secondary aim, the investigators will explore whether this brief intervention is associated with improvements in cognitive functioning immediately and one week following the intervention.

Subjects will be randomly assigned to one of two experimental groups: either the LIFUP administration will be designed to increase the activity of neurons in a certain part of the brain or decrease the activity of neurons.

The investigators will study up to 8 subjects with MCI or mild AD. Initially, subjects will undergo a screening assessment with a study physician to determine medical and psychiatric history, establish AD diagnosis, and undergo a blood draw, if standard recent labs for dementia and EKG are unavailable. Subjects that meet criteria and agree to participate in the study will undergo a follow-up visit. In the baseline measurement visit, participants will first undergo neuropsychological testing. Participants will be randomly assigned to one of two LIFUP pulsing paradigms. Participants will then be administered four successive LIFUP treatments while the participants are in a functional magnetic resonance imaging (MRI). Sixty minutes following the administration, participants will undergo a second neuropsychological test. A final follow-up assessment will be administered at one week.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Alzheimer's disease drug development pipeline: 2019.
   Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2019 · cited 485× · PMID 31334330 · DOI 10.1016/j.trci.2019.05.008
2. Therapy for Alzheimer's disease: Missing targets and functional markers?
   Stoiljkovic M, Horvath TL, Hajós M. · · 2021 · cited 52× · PMID 33711510 · DOI 10.1016/j.arr.2021.101318
3. In vivo imaging of sterile microglial activation in rat brain after disrupting the blood-brain barrier with pulsed focused ultrasound: [18F]DPA-714 PET study.
   Sinharay S, Tu TW, Kovacs ZI, Schreiber-Stainthorp W, et al · · 2019 · cited 51× · PMID 31345243 · DOI 10.1186/s12974-019-1543-z
4. Ultrasound Therapy: Experiences and Perspectives for Regenerative Medicine.
   de Lucas B, Pérez LM, Bernal A, Gálvez BG. · · 2020 · cited 38× · PMID 32957737 · DOI 10.3390/genes11091086
5. Low-intensity focused ultrasound for the treatment of brain diseases: safety and feasibility.
   Toccaceli G, Barbagallo G, Peschillo S. · · 2019 · cited 26× · PMID 30809291 · DOI 10.7150/thno.31765
6. Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
   Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991
7. Targeted manipulation of pain neural networks: The potential of focused ultrasound for treatment of chronic pain.
   Todd N, McDannold N, Borsook D. · · 2020 · cited 13× · PMID 32534900 · DOI 10.1016/j.neubiorev.2020.06.007
8. Low-intensity transcranial ultrasound neuromodulation promotes neuronal regeneration: A new hope for noninvasive treatment of neurodegenerative diseases.
   Xia S, He C, Li Y, Li H, et al · · 2026 · cited 1× · PMID 40817729 · DOI 10.4103/nrr.nrr-d-25-00113