Brain ImagingLIFUPNCT03347084
Deep Brain Stimulation with LIFUP for Mild Cognitive Impairment and Mild Alzheimer's Disease
A study testing Excitation and Inhibition in people with Brain Imaging and Mild Cognitive Impairment, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Brain Imaging, Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- Excitation and Inhibition
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2018to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild cognitive impairment or mild (early-stage) AD diagnosis through medical record review
- Agreement to participate in a clinical and brain imaging study.
- Age 55 years or older.
- No significant cerebrovascular disease as determined by a modified Ischemic Score of ≤ 4.
- Availability of a study partner (next of kin, family member) to attend all visits and to provide surrogate consent should it be determined that the participant does not have capacity.
- Adequate visual and auditory acuity to allow neuropsychological testing.
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- Screening laboratory tests and ECG without significant abnormalities that might interfere with the study.
- Use of cholinesterase inhibitors for AD (Aricept, Namenda, etc.) will be allowed as long as the participant has been on a stable dose for at least two months.
- There must be a family member or caregiver available to make sure the participant gives informed consent, and in case the participant develops cognitive impairment that interferes with independent study participation.
Who cannot join
- Evidence of any other major neurologic or other physical illness that could produce cognitive deterioration, except for mild cognitive impairment (MCI) and any history of stroke or diabetes.
- History of myocardial infarction within the previous year or unstable cardiac disease.
- Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100), history of significant liver disease, clinically significant pulmonary disease, diabetes, or cancer.
- Major psychiatric disorders, such as bipolar disorder or schizophrenia, or persons with current untreated major depression
- Current diagnosis or significant history of alcoholism or drug dependence.
- Participants taking medications known to influence cognitive functioning will be excluded. Medications that will be excluded include: centrally active beta-blockers, narcotics, clonidine, anti-Parkinsonian medications, benzodiazepines, systemic corticosteroids, and medications with significant anticholinergic effects, anti-convulsants, or warfarin. During the screening visit, physicians will review all medications and determine whether the type, dose, and interaction of medications are likely to impact cognition and determine exclusion based on these factors.
- Use of any investigational drugs within the previous month or longer, depending on the drug's half-life.
- Contraindication for fMRI scan (e.g. metal in body, claustrophobia).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Non-Invasive Deep Brain Stimulation with Low Intensity Focused Ultrasound Pulse (LIFUP) for Mild Cognitive Impairment (MCI) and Mild Alzheimer's Disease (AD)
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.
Read the detailed description
Alzheimer disease (AD) is a neurodegenerative condition and the most common cause of dementia or a functional impairment in memory and other cognitive abilities. Prior to developing the functional impairment of dementia, patients develop mild cognitive impairment (MCI), which increases the risk for developing the functional impairment of dementia. Deep brain stimulation (DBS) is of interest as a potential therapeutic option for MCI and AD because it can directly target and modulate the activity of brain structures implicated in memory functioning.
Recently there have been multiple reports that DBS of different locations within the brain may be effective in improving symptoms characteristic of dementia (e.g., Heschman et al., 2013). For example, Laxton et al. (2010) performed DBS in the fornix/hypothalamus of six persons with AD in a phase I clinical trial. The investigators hypothesized that stimulation of the fornix would alter the activity of the medial temporal memory circuits, and thus delay and/or reverse memory loss. After 6-12 months, the investigators noted improvement or slowing in the progression of AD in some of the research participants, as measured by two commonly-used assessments of global cognitive function. In a recent literature review, Laxton et al. (2013) also described several additional studies demonstrating that DBS of the fornix or nucleus of Meynert or subthalamic nucleus influences the pathologic neurological circuits involved in AD.
Four separate groups recently have published reports concluding that ultrasound improves amyloid-β clearance in mouse models and restores memory (e.g., Leinenga \& Götz, 2015). This finding raises the question of whether one method of DBS, Low Intensity Focused Ultrasound Pulse (LIFUP), could improve cognition in patients with AD, which is characterized by abnormal deposition of amyloid plaques in brain regions controlling memory and thinking. The use of LIFUP in animal models is well described (Bystritsky et al., 2014). LIFUP is able to penetrate the human skull and reach deep structures within the temporal therapeutic window. The structures that are reachable by LIFUP include the temporal cortices, hippocampus, thalamus, and subthalamic nuclei, all of which are implicated in the pathophysiology of AD. The Food and Drug Administration (FDA) recently approved an investigational device exemption (IDE) to begin a feasibility and safety trial of LIFUP for persons with refractory seizures.
Although symptomatic treatments are available for AD, their modest effects are temporary and there is a need for more effective interventions. In the current project, the investigators propose to use the FDA-approved protocol to:
- Determine the feasibility of a brief LIFUP intervention (four stimulations of 30 seconds each, with 2-minute intervals between each treatment) for persons with MCI or mild (early-stage) AD.
- As a secondary aim, the investigators will explore whether this brief LIFUP intervention is associated with improvements on neuropsychological measures of cognitive functioning immediately following the intervention.
To investigate these aims, subjects with MCI or mild AD will be enrolled. Subjects will be randomized using a single-blind design, to one of two LIFUP pulsing paradigms in which activity of neurons in a certain part of the brain are either increased. Subjects will then be administered four successive LIFUP treatments while the subjects are in a functional magnetic resonance imaging (MRI). Neuropsychological assessments will be performed at baseline, immediately after LIFUP is administered, and one week following the conclusion of the visit.
- Being tested
- Excitation, Inhibition
- Keywords
- DBS, brain imaging, Memory, fMRI
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExcitationDevice
Also called Low Intensity Focused Ultrasound Pulse
Administration of LIFUP, a method of deep brain stimulation, according to excitation paradigms using the following parameters: Tone Burst Duration = 50ms; Pulse Repetition Frequency = 10Hz; ISPTA = 720 mW/cm2. Four treatments of thirty seconds each, with two-minute intervals between treatment (20 minutes, approximately)
InhibitionDevice
Also called Low Intensity Focused Ultrasound Pulse
Administration of LIFUP, a method of deep brain stimulation, according to inhibition paradigms using the following parameters: Tone Burst Duration = 50ms and Pulse Repetition Frequency = 10Hz. Four treatments of thirty seconds each, with two-minute intervals between treatment (20 minutes, approximately)
| Study group | Role | What they receive |
|---|---|---|
| Excitation | Active comparator | Excitation Paradigm: LIFUP excites the activity of hippocampal neurons. Receives: Device: Excitation |
| Inhibition | Active comparator | Inhibition Paradigm: LIFUP inhibits the activity of hippocampal neurons. Receives: Device: Inhibition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in fMRI brain scan to 40 minutes.
Functional MRI of the brain will be obtained throughout the LIFUP session for the purposes of image acquisition.
Measured: 40 Minutes
Secondary outcomes (3)
Change from baseline in Hopkins Verbal Learning Test-Revised45 (HVLT-R)
The Hopkins Verbal Learning Test-Revised will provide a measure of verbal memory. It requires recall of a series of 12 words over three learning trials, free recall after a 25-minute delay, and a recognition trial. There are 6 equivalent alternate forms.
Measured: 60 Minutes, 1 Week
Change from baseline in Brief Visual Memory Test-Revised
The Brief Visual Memory Test-Revised will provide a measure of visual memory. In three learning trials, the respondent views 6 geometric figures for 10 seconds and is asked to draw as many of the figures as possible from memory in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Last, a Recognition Trial, in which the respondent is asked to identify which of 12 figures were included among the original geometric figures, is administered. There are 6 equivalent alternate forms.
Measured: 60 Minutes, 1 Week
Change from baseline in Geriatric Anxiety Inventory (GAI)
Geriatric Anxiety Inventory (GAI) will be used as a measure to ensure that pre-LIFUP/pre-MRI anxiety is not significantly impacting performance on the first neuropsychological assessment.
Measured: 60 Minutes, 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start10 Nov 2018
- Primary completion31 Mar 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Brain ImagingStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two LIFUP pulsing paradigms: one that excites the activity of hippocampal neurons ("Paradigm A"), or a second that inhibits them ("Paradigm B"). The participants will then be administered four successive LIFUP treatments while the participants are in a functional magnetic resonance imaging (MRI).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taylor Kuhn, University of California, Los Angeles
- Investigators
- Taylor P Kuhn, PhD, Principal investigator, UCLA Longevity Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347084
- Sponsor's protocol ID
- 16-001314
- Acronym
- LIFUP
- Status last verified
- Aug 2024
- First submitted
- 15 Nov 2017
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
World Health Organization (WHO). Dementia cases set to triple by 2050 but still largely ignored. Geneva, Switzerland; 2012.
Prince M, Bryce R, Ferri C. World Alzheimer report. Alzheimer's Disease International; 2011 Sep.
Okun MS. Deep-brain stimulation for Parkinson's disease. N Engl J Med. 2013 Jan 31;368(5):483-4. doi: 10.1056/NEJMc1214078. No abstract available.
PubMed 23363512Halpern C, Hurtig H, Jaggi J, Grossman M, Won M, Baltuch G. Deep brain stimulation in neurologic disorders. Parkinsonism Relat Disord. 2007 Feb;13(1):1-16. doi: 10.1016/j.parkreldis.2006.03.001. Epub 2006 Dec 1.
PubMed 17141550Mayberg HS, Lozano AM, Voon V, McNeely HE, Seminowicz D, Hamani C, Schwalb JM, Kennedy SH. Deep brain stimulation for treatment-resistant depression. Neuron. 2005 Mar 3;45(5):651-60. doi: 10.1016/j.neuron.2005.02.014.
PubMed 15748841Greenberg BD, Malone DA, Friehs GM, Rezai AR, Kubu CS, Malloy PF, Salloway SP, Okun MS, Goodman WK, Rasmussen SA. Three-year outcomes in deep brain stimulation for highly resistant obsessive-compulsive disorder. Neuropsychopharmacology. 2006 Nov;31(11):2384-93. doi: 10.1038/sj.npp.1301165. Epub 2006 Jul 19.
PubMed 16855529Stephen JH, Halpern CH, Barrios CJ, Balmuri U, Pisapia JM, Wolf JA, Kampman KM, Baltuch GH, Caplan AL, Stein SC. Deep brain stimulation compared with methadone maintenance for the treatment of heroin dependence: a threshold and cost-effectiveness analysis. Addiction. 2012 Mar;107(3):624-34. doi: 10.1111/j.1360-0443.2011.03656.x.
PubMed 21919988Pisapia JM, Halpern CH, Williams NN, Wadden TA, Baltuch GH, Stein SC. Deep brain stimulation compared with bariatric surgery for the treatment of morbid obesity: a decision analysis study. Neurosurg Focus. 2010 Aug;29(2):E15. doi: 10.3171/2010.5.FOCUS10109.
PubMed 20672917Hescham S, Lim LW, Jahanshahi A, Blokland A, Temel Y. Deep brain stimulation in dementia-related disorders. Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 2):2666-75. doi: 10.1016/j.neubiorev.2013.09.002. Epub 2013 Sep 20.
PubMed 24060532Hardenacke K, Kuhn J, Lenartz D, Maarouf M, Mai JK, Bartsch C, Freund HJ, Sturm V. Stimulate or degenerate: deep brain stimulation of the nucleus basalis Meynert in Alzheimer dementia. World Neurosurg. 2013 Sep-Oct;80(3-4):S27.e35-43. doi: 10.1016/j.wneu.2012.12.005. Epub 2012 Dec 12.
PubMed 23246738Fontaine D, Deudon A, Lemaire JJ, Razzouk M, Viau P, Darcourt J, Robert P. Symptomatic treatment of memory decline in Alzheimer's disease by deep brain stimulation: a feasibility study. J Alzheimers Dis. 2013;34(1):315-23. doi: 10.3233/JAD-121579.
PubMed 23168448Sankar T, Tierney TS, Hamani C. Novel applications of deep brain stimulation. Surg Neurol Int. 2012;3(Suppl 1):S26-33. doi: 10.4103/2152-7806.91607. Epub 2012 Jan 14.
PubMed 22826807Laxton AW, Lozano AM. Deep brain stimulation for the treatment of Alzheimer disease and dementias. World Neurosurg. 2013 Sep-Oct;80(3-4):S28.e1-8. doi: 10.1016/j.wneu.2012.06.028. Epub 2012 Jun 19.
PubMed 22722036Vitek JL. Long-term benefit from deep brain stimulation of the subthalamic nucleus: is it for everyone? Alzheimers Res Ther. 2012 May 9;4(3):13. doi: 10.1186/alzrt111.
PubMed 22574875Smith GS, Laxton AW, Tang-Wai DF, McAndrews MP, Diaconescu AO, Workman CI, Lozano AM. Increased cerebral metabolism after 1 year of deep brain stimulation in Alzheimer disease. Arch Neurol. 2012 Sep;69(9):1141-8. doi: 10.1001/archneurol.2012.590.
PubMed 22566505
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Non-Invasive Deep Brain Stimulation with Low Intensity Focused Ultrasound Pulse (LIFUP) for Mild Cognitive Impairment (MCI) and Mild Alzheimer's Disease (AD)
- ClinicalTrials.gov ID
- NCT03347084
- Acronym / sponsor ID
- LIFUP / 16-001314
- Keywords
- DBS, brain imaging, Memory, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Alzheimer disease (AD) is a neurodegenerative condition and the most common cause of dementia or a functional impairment in memory and other cognitive abilities. Prior to developing the functional impairment of dementia, patients develop mild cognitive impairment (MCI), which increases the risk for developing the functional impairment of dementia. Deep brain stimulation (DBS) is of interest as a potential therapeutic option for MCI and AD because it can directly target and modulate the activity of brain structures implicated in memory functioning.
Recently there have been multiple reports that DBS of different locations within the brain may be effective in improving symptoms characteristic of dementia (e.g., Heschman et al., 2013). For example, Laxton et al. (2010) performed DBS in the fornix/hypothalamus of six persons with AD in a phase I clinical trial. The investigators hypothesized that stimulation of the fornix would alter the activity of the medial temporal memory circuits, and thus delay and/or reverse memory loss. After 6-12 months, the investigators noted improvement or slowing in the progression of AD in some of the research participants, as measured by two commonly-used assessments of global cognitive function. In a recent literature review, Laxton et al. (2013) also described several additional studies demonstrating that DBS of the fornix or nucleus of Meynert or subthalamic nucleus influences the pathologic neurological circuits involved in AD.
Four separate groups recently have published reports concluding that ultrasound improves amyloid-β clearance in mouse models and restores memory (e.g., Leinenga \& Götz, 2015). This finding raises the question of whether one method of DBS, Low Intensity Focused Ultrasound Pulse (LIFUP), could improve cognition in patients with AD, which is characterized by abnormal deposition of amyloid plaques in brain regions controlling memory and thinking. The use of LIFUP in animal models is well described (Bystritsky et al., 2014). LIFUP is able to penetrate the human skull and reach deep structures within the temporal therapeutic window. The structures that are reachable by LIFUP include the temporal cortices, hippocampus, thalamus, and subthalamic nuclei, all of which are implicated in the pathophysiology of AD. The Food and Drug Administration (FDA) recently approved an investigational device exemption (IDE) to begin a feasibility and safety trial of LIFUP for persons with refractory seizures.
Although symptomatic treatments are available for AD, their modest effects are temporary and there is a need for more effective interventions. In the current project, the investigators propose to use the FDA-approved protocol to:
- Determine the feasibility of a brief LIFUP intervention (four stimulations of 30 seconds each, with 2-minute intervals between each treatment) for persons with MCI or mild (early-stage) AD.
- As a secondary aim, the investigators will explore whether this brief LIFUP intervention is associated with improvements on neuropsychological measures of cognitive functioning immediately following the intervention.
To investigate these aims, subjects with MCI or mild AD will be enrolled. Subjects will be randomized using a single-blind design, to one of two LIFUP pulsing paradigms in which activity of neurons in a certain part of the brain are either increased. Subjects will then be administered four successive LIFUP treatments while the subjects are in a functional magnetic resonance imaging (MRI). Neuropsychological assessments will be performed at baseline, immediately after LIFUP is administered, and one week following the conclusion of the visit.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two LIFUP pulsing paradigms: one that excites the activity of hippocampal neurons ("Paradigm A"), or a second that inhibits them ("Paradigm B"). The participants will then be administered four successive LIFUP treatments while the participants are in a functional magnetic resonance imaging (MRI).
| Arm | Type | Receives |
|---|---|---|
| Excitation | Active comparator | Device: ExcitationExcitation Paradigm: LIFUP excites the activity of hippocampal neurons. |
| Inhibition | Active comparator | Device: InhibitionInhibition Paradigm: LIFUP inhibits the activity of hippocampal neurons. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Mild cognitive impairment or mild (early-stage) AD diagnosis through medical record review
- Agreement to participate in a clinical and brain imaging study.
- Age 55 years or older.
- No significant cerebrovascular disease as determined by a modified Ischemic Score of ≤ 4.
- Availability of a study partner (next of kin, family member) to attend all visits and to provide surrogate consent should it be determined that the participant does not have capacity.
Key exclusion criteria (8 listed)
- Evidence of any other major neurologic or other physical illness that could produce cognitive deterioration, except for mild cognitive impairment (MCI) and any history of stroke or diabetes.
- History of myocardial infarction within the previous year or unstable cardiac disease.
- Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100), history of significant liver disease, clinically significant pulmonary disease, diabetes, or cancer.
- Major psychiatric disorders, such as bipolar disorder or schizophrenia, or persons with current untreated major depression
- Current diagnosis or significant history of alcoholism or drug dependence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExcitationAlso: Low Intensity Focused Ultrasound PulseAdministration of LIFUP, a method of deep brain stimulation, according to excitation paradigms using the following parameters: Tone Burst Duration = 50ms; Pulse Repetition Frequency = 10Hz; ISPTA = 720 mW/cm2. Four treatments of thirty seconds each, with two-minute intervals between treatment (20 minutes, approximately) | Device | Excitation |
| InhibitionAlso: Low Intensity Focused Ultrasound PulseAdministration of LIFUP, a method of deep brain stimulation, according to inhibition paradigms using the following parameters: Tone Burst Duration = 50ms and Pulse Repetition Frequency = 10Hz. Four treatments of thirty seconds each, with two-minute intervals between treatment (20 minutes, approximately) | Device | Inhibition |
Primary outcome
Change from baseline in fMRI brain scan to 40 minutes.
Time frame: 40 Minutes
Functional MRI of the brain will be obtained throughout the LIFUP session for the purposes of image acquisition.
3 secondary outcomes
Change from baseline in Hopkins Verbal Learning Test-Revised45 (HVLT-R)
Time frame: 60 Minutes, 1 Week
Change from baseline in Brief Visual Memory Test-Revised
Time frame: 60 Minutes, 1 Week
Change from baseline in Geriatric Anxiety Inventory (GAI)
Time frame: 60 Minutes, 1 Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- BackgroundWorld Health Organization (WHO). Dementia cases set to triple by 2050 but still largely ignored. Geneva, Switzerland; 2012.
- BackgroundPrince M, Bryce R, Ferri C. World Alzheimer report. Alzheimer's Disease International; 2011 Sep.
- Background: PubMed 23363512Okun MS. Deep-brain stimulation for Parkinson's disease. N Engl J Med. 2013 Jan 31;368(5):483-4. doi: 10.1056/NEJMc1214078. No abstract available.
- Background: PubMed 17141550Halpern C, Hurtig H, Jaggi J, Grossman M, Won M, Baltuch G. Deep brain stimulation in neurologic disorders. Parkinsonism Relat Disord. 2007 Feb;13(1):1-16. doi: 10.1016/j.parkreldis.2006.03.001. Epub 2006 Dec 1.
- Background: PubMed 15748841Mayberg HS, Lozano AM, Voon V, McNeely HE, Seminowicz D, Hamani C, Schwalb JM, Kennedy SH. Deep brain stimulation for treatment-resistant depression. Neuron. 2005 Mar 3;45(5):651-60. doi: 10.1016/j.neuron.2005.02.014.
- Background: PubMed 16855529Greenberg BD, Malone DA, Friehs GM, Rezai AR, Kubu CS, Malloy PF, Salloway SP, Okun MS, Goodman WK, Rasmussen SA. Three-year outcomes in deep brain stimulation for highly resistant obsessive-compulsive disorder. Neuropsychopharmacology. 2006 Nov;31(11):2384-93. doi: 10.1038/sj.npp.1301165. Epub 2006 Jul 19.
- Background: PubMed 21919988Stephen JH, Halpern CH, Barrios CJ, Balmuri U, Pisapia JM, Wolf JA, Kampman KM, Baltuch GH, Caplan AL, Stein SC. Deep brain stimulation compared with methadone maintenance for the treatment of heroin dependence: a threshold and cost-effectiveness analysis. Addiction. 2012 Mar;107(3):624-34. doi: 10.1111/j.1360-0443.2011.03656.x.
- Background: PubMed 20672917Pisapia JM, Halpern CH, Williams NN, Wadden TA, Baltuch GH, Stein SC. Deep brain stimulation compared with bariatric surgery for the treatment of morbid obesity: a decision analysis study. Neurosurg Focus. 2010 Aug;29(2):E15. doi: 10.3171/2010.5.FOCUS10109.
- Background: PubMed 24060532Hescham S, Lim LW, Jahanshahi A, Blokland A, Temel Y. Deep brain stimulation in dementia-related disorders. Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 2):2666-75. doi: 10.1016/j.neubiorev.2013.09.002. Epub 2013 Sep 20.
- Background: PubMed 23246738Hardenacke K, Kuhn J, Lenartz D, Maarouf M, Mai JK, Bartsch C, Freund HJ, Sturm V. Stimulate or degenerate: deep brain stimulation of the nucleus basalis Meynert in Alzheimer dementia. World Neurosurg. 2013 Sep-Oct;80(3-4):S27.e35-43. doi: 10.1016/j.wneu.2012.12.005. Epub 2012 Dec 12.
- Background: PubMed 23168448Fontaine D, Deudon A, Lemaire JJ, Razzouk M, Viau P, Darcourt J, Robert P. Symptomatic treatment of memory decline in Alzheimer's disease by deep brain stimulation: a feasibility study. J Alzheimers Dis. 2013;34(1):315-23. doi: 10.3233/JAD-121579.
- Background: PubMed 22826807Sankar T, Tierney TS, Hamani C. Novel applications of deep brain stimulation. Surg Neurol Int. 2012;3(Suppl 1):S26-33. doi: 10.4103/2152-7806.91607. Epub 2012 Jan 14.
- Analysis Group, Oxford, UK. FMRIB Software Library v5.0.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taylor P Kuhn, PhD principal investigator
UCLA Longevity Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excitation and Inhibition in people with Brain Imaging and Mild Cognitive Impairment, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in fMRI brain scan to 40 minutes. (time frame: 40 Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03347084, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.