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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
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.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
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.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Associative memory performance change
Object recognition memory performance change
Verbal recall performance change
Secondary outcome measures
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.
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Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,538 Previous Clinical Trials
10,266,961 Total Patients Enrolled
3 Trials studying Memory Disorders
191 Patients Enrolled for Memory Disorders
National Institute on Aging (NIA)NIH
1,692 Previous Clinical Trials
28,027,144 Total Patients Enrolled
19 Trials studying Memory Disorders
4,975 Patients Enrolled for Memory Disorders
Nanthia SuthanaPrincipal Investigator - University of California, Los Angeles
University of California, Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with dementia.I can perform most daily activities without help.Your score on the PHQ (Patient Health Questionnaire) is higher than 7.I have never had a stroke, traumatic brain injury, epilepsy, Huntington's, or Parkinson's.I can perform most daily activities without help, despite my memory issues.I live on my own without needing daily help.I may be taking benzodiazepines, depending on the dose it might be okay.You use your right hand more often than your left hand.I do not speak English.I cannot have an MRI due to claustrophobia, metal in my body, recent surgery, certain implants, or past bad MRI results.I am currently taking a sedating antihistamine like Benadryl.I am currently taking medication for muscle spasms or bladder issues.I am not taking medications like certain antidepressants that have strong anticholinergic or antihistaminic effects.I can see and hear well enough for brain function tests.I am between 55 and 90 years old.I haven't changed my mental health meds in the last month.I do not have major psychiatric or neurological disorders affecting my thinking.I have undergone TMS treatment before.You have a current or past problem with alcohol or drug abuse.I have high blood pressure or heart disease that is not well-managed.You have had problems with alcohol or drugs (excluding nicotine and caffeine) within the last six months.You have not gotten enough sleep.I have not had a head injury or diseases affecting my brain.I have been diagnosed with mild cognitive impairment.You have been experiencing memory problems and have reported them yourself, with a positive score on a memory function questionnaire.
Research Study Groups:
This trial has the following groups:- Group 1: Active TBS
- Group 2: Sham TBS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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