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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 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.

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

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.

Find a Location

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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment involve participants aged sixty or above?

"To be eligible for this clinical trial, patients must fall within the age range of 55 to 90. There are 28 trials with participants below 18 and an additional 551 for those above 65 years old."

Answered by AI

What type of participants would best suit this trial?

"This medical trial is recruiting a cohort of 70 elderly patients who display signs of cognitive decline, ranging between 55 and 90 years old. Eligible participants must meet the aforementioned age requirements in addition to demonstrating right-handedness, providing informed consent for longitudinal study, meeting DSM-5 criteria for mild neurocognitive disorder (NCD), being generally healthy with no abnormalities interfering with the procedure, displaying proficiency in English language reading/writing/speaking skills as well as sufficient visual/auditory acuity that allows running neuropsychological tests, living independently without requiring assistance from others and exhibiting subjective memory deficits evidenced by self-report or positive score on Memory"

Answered by AI

Is there still opportunity for participants to partake in this research?

"Affirmative, the clinicaltrials.gov page shows that this research endeavour is actively looking for participants. This study was initially announced on January 26th 2021 and last modified on April 13th 2022; it seeks to enroll 70 patients at a single site."

Answered by AI

What is the scope of enrolment for this medical experiment?

"Affirmative. Clinicaltrials.gov lists the trial as currently open for enrollment, with a start date of January 26th 2021 and an update on April 13th 2022. The experiment requires 70 individuals to be recruited from 1 centre."

Answered by AI
~2 spots leftby Jun 2024