Cognitive DysfunctionNCT04558164
Network-targeted Theta-burst Stimulation for Episodic Memory Improvement in Mild Cognitive Impairment
A study testing Active Theta Burst Stimulation in people with Cognitive Dysfunction and Memory Disorders in Old Age, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to see if stimulation of the brain can improve memory. The investigators will use a device called transcranial magnetic stimulation that can stimulate and activate a specific part of the brain that is important for memory. Read more about this study
- Who is it for?
- Ages 55 to 100 years
- Conditions the study is for
- Cognitive Dysfunction, Memory Disorders in Old Age
- What is being tested?
- Active Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2021to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agreement to participate in the study
- 55-100 years of age
- Right-handedness
- In good general health
- Living independently
- Subjective memory complaints (self-report and positive score on MFQ)
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- Katz ADL scale and Lawton iADL scale: We will review scores on a case-by-case basis if they did not score 100%. We will exclude if the scores show impairment in ADLs that suggests problems with independent functioning due to cognitive impairment.
- MMSE score > 24
- PHQ Depression score =< 7
- Ability to read, write, and speak English fluently
- Diagnosis of mild neurocognitive disorder according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria. Participants with subjective memory complaints without an aMCI diagnosis will be reviewed on a case-by-case basis based on neuropsychological scores. Participants scoring a raw score of 0 or 3 standard deviations below normative expectations on the long delay recall in two or more of the three tasks (BVMT-R, RCFT, and CVLT-III) will be excluded.
- No change in use of psychotropic medication for treatment of depression, anxiety, ADHS or psychosis 1 month prior and during the study.
- Screening diagnostic criteria for aMCI will be subjective memory complaints, intact instrumental and basic activities of daily living (Smith et al., 1996), PHQ, MMSE, BVMT-R (25-minute delay), CVLT-II (20-minute delay), Rey-Osterrieth Complex Figure Task (30-minute delay). Baseline assessments will include neuropsychological testing of all study subjects.
Who cannot join
- Unwilling or unable to provide informed consent
- Diagnosis of dementia
- Active major medical, psychiatric, or neurologic disorder associated with neurocognitive impairment
- History of alcohol or substance abuse
- Recent (< 6 months) alcohol or substance abuse (excluding nicotine or caffeine)
- History of stroke (if the stroke in our judgment is related to the memory problem), traumatic brain injury with loss of consciousness, or other neurologic disorder (e.g., epilepsy, Huntington's disease, Parkinson's disease)
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- Non-English speaking participants
- Not right handed based on self-report or evaluation based on a standard report
- Has received TMS before (not TMS naïve)
- Poorly controlled hypertension or cardiovascular disease
- Current enrollment in a memory-enhancement study or course
- Contraindication to TMS or MRI including claustrophobia, metal in body, surgery within 60 days, certain implants, or previous abnormal MRI results.
- scanning facial tattoos is okay if safe with MRI
- is taking:
- anticholinergic medication (e.g., Detrol, Cogentin);
- sedating antihistamine (e.g., Benadryl);
- any drug that has significant anticholinergic or antihistaminic side effects (e.g., tricyclic antidepressant medications, Remeron).
- benzodiazepines. While not a strict rule out, this will be decided on a case-by-case basis depending on the dose.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Los Angeles
Los Angeles, California, 90024
About this study
The purpose of this study is to see if stimulation of the brain can improve memory. The investigators will use a device called transcranial magnetic stimulation that can stimulate and activate a specific part of the brain that is important for memory. The study will enroll MCI subjects and subjects with subjective memory complaints who will be randomly assigned to receive active or sham brain stimulation. 'Blinded' or 'sham-controlled' means that the subject will not know whether the treatment they receive is the active treatment or the non-active stimulation. In the 'sham' condition, the stimulator will turn on but will not actually be stimulating the target brain region.
- Conditions
- Cognitive Dysfunction, Memory Disorders in Old Age
- Being tested
- Active Theta Burst Stimulation, Sham Theta Burst Stimulation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Theta Burst StimulationDevice
Theta burst transcranial magnetic stimulation (TBS) will be delivered at 80-100% of motor threshold (MT).
Sham Theta Burst StimulationDevice
Sham stimulation will be delivered at 0-10% of motor threshold (MT), with all other parameters matching the active TBS condition.
| Study group | Role | What they receive |
|---|---|---|
| Active TBS | Experimental | Theta burst stimulation (TBS) will be delivered at 100% of motor threshold (MT). Receives: Device: Active Theta Burst Stimulation |
| Sham TBS | Sham comparator | Sham stimulation will be delivered at 0% of motor threshold (MT), with all other parameters matching the active TBS condition. Receives: Device: Sham Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal recall performance change
Verbal memory will be measured using a free recall task where participants learn a list of everyday words and are asked to recall as many words as they can remember after a period of distraction. Proportion of recollected words will be used to quantify memory performance changes.
Measured: Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20.
Object recognition memory performance change
Object memory will be measured using an recognition task where participants view photos of everyday objects and are asked to identify them as OLD or NEW during a memory test wherein unseen novel objects and very similar but new photos of identical objects are shown. Recollection and discrimination index will be used to quantify memory performance changes.
Measured: Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20.
Associative memory performance change
Associative memory will be tested using the Face Name Memory Test wherein participants are shown faces and associated names. Participants are then shown faces only and asked to recall the associated name.
Measured: Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20.
Secondary outcomes (2)
Resting state fMRI functional connectivity
Resting state fMRI activity will be measured before the first and after the last TBS treatment
Measured: Baseline (Day 2) before the first treatment and after the last treatment (Day 17)
EEG activity
EEG functional connectivity with stimulated region and medial temporal source localized power in the theta band will be recorded during a resting period as well as during the treatment itself both before and after treatments
Measured: During treatment (Days 3, 7 and 12), after the last treatment (Day 17), and 2 month follow-up session (Day 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start26 Jan 2021
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Andrew F. Leuchter, University of California, Los Angeles
- Investigators
- Andrew Leuchter, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558164
- Sponsor's protocol ID
- 20-001417
- Other IDs
- R01AG068317
- Status last verified
- Aug 2026
- First submitted
- 4 Sep 2020
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The data collected for this research represent a valuable resource to the scientific community, and the PIs will make them accessible to others, while respecting the special needs for confidentiality. All data will be anonymized before being provided to the scientific community. Researchers can also request access to the data under collaborative and co-authorship agreements prior to the end of the funding period or before publication. The results from the proposed project will also be shared at scientific meetings (local, national and international) as well via published manuscripts.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Network-targeted Theta-burst Stimulation for Episodic Memory Improvement in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04558164
- Acronym / sponsor ID
- 20-001417
- Conditions
- Cognitive Dysfunction, Memory Disorders in Old Age
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 22 Sep 2020 (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 this study is to see if stimulation of the brain can improve memory. The investigators will use a device called transcranial magnetic stimulation that can stimulate and activate a specific part of the brain that is important for memory. The study will enroll MCI subjects and subjects with subjective memory complaints who will be randomly assigned to receive active or sham brain stimulation. 'Blinded' or 'sham-controlled' means that the subject will not know whether the treatment they receive is the active treatment or the non-active stimulation. In the 'sham' condition, the stimulator will turn on but will not actually be stimulating the target brain region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TBS | Experimental | Device: Active Theta Burst StimulationTheta burst stimulation (TBS) will be delivered at 100% of motor threshold (MT). |
| Sham TBS | Sham comparator | Device: Sham Theta Burst StimulationSham stimulation will be delivered at 0% of motor threshold (MT), with all other parameters matching the active TBS condition. |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Agreement to participate in the study
- 55-100 years of age
- Right-handedness
- In good general health
- Living independently
Key exclusion criteria (18 listed)
- Unwilling or unable to provide informed consent
- Diagnosis of dementia
- Active major medical, psychiatric, or neurologic disorder associated with neurocognitive impairment
- History of alcohol or substance abuse
- Recent (< 6 months) alcohol or substance abuse (excluding nicotine or caffeine)
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 |
|---|---|---|
| Active Theta Burst StimulationTheta burst transcranial magnetic stimulation (TBS) will be delivered at 80-100% of motor threshold (MT). | Device | Active TBS |
| Sham Theta Burst StimulationSham stimulation will be delivered at 0-10% of motor threshold (MT), with all other parameters matching the active TBS condition. | Device | Sham TBS |
Primary outcome
Verbal recall performance change
Time frame: Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20.
Verbal memory will be measured using a free recall task where participants learn a list of everyday words and are asked to recall as many words as they can remember after a period of distraction. Proportion of recollected words will be used to quantify memory performance changes.
Object recognition memory performance change
Time frame: Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20.
Object memory will be measured using an recognition task where participants view photos of everyday objects and are asked to identify them as OLD or NEW during a memory test wherein unseen novel objects and very similar but new photos of identical objects are shown. Recollection and discrimination index will be used to quantify memory performance changes.
Associative memory performance change
Time frame: Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20.
Associative memory will be tested using the Face Name Memory Test wherein participants are shown faces and associated names. Participants are then shown faces only and asked to recall the associated name.
2 secondary outcomes
Resting state fMRI functional connectivity
Time frame: Baseline (Day 2) before the first treatment and after the last treatment (Day 17)
EEG activity
Time frame: During treatment (Days 3, 7 and 12), after the last treatment (Day 17), and 2 month follow-up session (Day 20)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Yes. The data collected for this research represent a valuable resource to the scientific community, and the PIs will make them accessible to others, while respecting the special needs for confidentiality. All data will be anonymized before being provided to the scientific community. Researchers can also request access to the data under collaborative and co-authorship agreements prior to the end of the funding period or before publication. The results from the proposed project will also be shared at scientific meetings (local, national and international) as well via published manuscripts.
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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.
Andrew Leuchter, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Theta Burst Stimulation in people with Cognitive Dysfunction and Memory Disorders in Old Age, 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 13 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Verbal recall performance change (time frame: Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.