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Theta-burst Stimulation for Memory Improvement in Mild Cognitive Impairment

N/A
Recruiting
Led By Nanthia Suthana
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
55-90 years of age
Diagnosis of mild neurocognitive disorder according to DSM-5 criteria
Must not have
Diagnosis of dementia
Active major psychiatric or neurologic disorders associated with neurocognitive impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline: day 2; during stimulation: day 3, day 7, day 12, day 17; follow-up appointments: day 18, day 19, day 20.

Summary

This trial is testing whether transcranial magnetic stimulation can help improve memory for people with mild cognitive impairment. The study will enroll people with MCI who will be randomly assigned to receive active or sham brain stimulation, where they won't know if they're receiving the real treatment or not.

Who is the study for?
This trial is for individuals aged 55-90 with mild cognitive impairment, who are in good health, right-handed, and speak English fluently. They should have memory complaints verified by specific tests and be able to consent to a long-term study. Excluded are those with dementia, major psychiatric or neurological disorders, substance abuse issues, certain medication use, or contraindications to MRI.
What is being tested?
The trial examines whether brain stimulation using transcranial magnetic stimulation (TMS) can improve memory in people with mild cognitive impairment. Participants will be randomly assigned to receive either active TMS or sham (fake) treatment without knowing which one they're getting.
What are the potential side effects?
While the description doesn't specify side effects of Theta Burst Stimulation directly, common ones from similar procedures may include headache, scalp discomfort at the site of stimulation, lightheadedness or seizures in very rare cases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 55 and 90 years old.
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I have been diagnosed with mild cognitive impairment.
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I live on my own without needing daily help.
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I can perform most daily activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with dementia.
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I do not have major psychiatric or neurological disorders affecting my thinking.
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I have never had a stroke, traumatic brain injury, epilepsy, Huntington's, or Parkinson's.
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I do not speak English.
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I have undergone TMS treatment before.
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I have not had a head injury or diseases affecting my brain.
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I have high blood pressure or heart disease that is not well-managed.
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I am currently taking medication for muscle spasms or bladder issues.
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I am currently taking a sedating antihistamine like Benadryl.
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I am not taking medications like certain antidepressants that have strong anticholinergic or antihistaminic effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline: day 2; during stimulation: day 3, day 7, day 12, day 17; follow-up appointments: day 18, day 19, day 20.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline: day 2; during stimulation: day 3, day 7, day 12, day 17; follow-up appointments: day 18, day 19, day 20. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Associative memory performance change
Object recognition memory performance change
Verbal recall performance change
Secondary study objectives
EEG activity
Resting state fMRI functional connectivity

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active TBSExperimental Treatment1 Intervention
Theta burst stimulation (TBS) will be delivered at 100% of motor threshold (MT).
Group II: Sham TBSPlacebo Group1 Intervention
Sham stimulation will be delivered at 0% of motor threshold (MT), with all other parameters matching the active TBS condition.

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,569 Previous Clinical Trials
10,314,225 Total Patients Enrolled
4 Trials studying Memory Disorders
266 Patients Enrolled for Memory Disorders
National Institute on Aging (NIA)NIH
1,803 Previous Clinical Trials
28,193,941 Total Patients Enrolled
27 Trials studying Memory Disorders
6,016 Patients Enrolled for Memory Disorders
Nanthia SuthanaPrincipal Investigator - University of California, Los Angeles
University of California, Los Angeles

Media Library

Active Theta Burst Stimulation Clinical Trial Eligibility Overview. Trial Name: NCT04558164 — N/A
Memory Disorders Research Study Groups: Active TBS, Sham TBS
Memory Disorders Clinical Trial 2023: Active Theta Burst Stimulation Highlights & Side Effects. Trial Name: NCT04558164 — N/A
Active Theta Burst Stimulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04558164 — N/A
~7 spots leftby May 2025