Network-targeted Theta-burst Stimulation for Episodic Memory Improvement in Mild Cognitive Impairment
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- STATUS
- Recruiting
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- End date
- Jun 30, 2025
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- participants needed
- 70
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- sponsor
- University of California, Los Angeles
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. The study will enroll subjects aged 55-100 with Mild Cognitive Impairment (MCI) who will be randomly assigned to receive active or sham brain stimulation.
Description
Study schedule: Participants will be assigned to 20 total visits:
- Days 3-17 will be 15 consecutive weekdays (Mon-Fri) of 30 min - 1 hr sessions of stimulation delivered on each day. A few of these sessions will also include EEG recordings and will last 2-3 hrs
- Before the 1st stimulation session (day 2) and immediately following the last stimulation session (day 17), subjects will complete a brain imaging (fMRI) study that will in total take between 1-1.5 hours. The 1st day of brain images will be used to identify the brain area involved in memory that will be stimulated. The second set of brain images taken after the last stimulation session will be used to see how stimulation affects memory and brain activity.
- On Day 18, which will be 24-72 hours after the last stimulation, subjects will come in to complete follow-up memory tasks.
- Days 19 and 20 will be scheduled 2 months after completion of the last stimulation session. Over these two sessions, subjects will complete memory tasks and neuropsychological evaluations.
- Doing memory assessments in the form of interview-style conversations, paper-and pencil questionnaires, computer tests, or other activities.
- Having MRI brain scans (described below).
- Having the assigned brain stimulation (described below).
- The brain scan is an MRI. For this, you will lie inside the scanning machine for about an hour while it takes a 3-D image of your brain.
- The brain stimulation is Transcranial Magnetic Stimulation (TMS). For this, a coil of wire inside a plastic casing will be placed against the surface of your scalp. Electricity will be passed through the coil in short pulses, creating magnetic fields. The magnetic fields will stimulate areas of the brain. Each session takes about 1 hour.
- The effect of TMS will be compared with the effect of sham treatment. For sham treatment, there will be pretend sessions that look and sound the same as active TMS, but no electricity will be passed through the coil.
- During the study, you will be assigned to have either: Active TMS; or Sham TMS. This will be determined randomly before the study starts, similar to flipping a coin.
- Both you and the researchers will not know whether you are getting the active TMS or placebo TMS until after the study is over.
- Participants will receive $600. Participants can also have a picture of their brain and a report of their first neuropsychological assessment once the study is completed.
- If it is revealed the participant was in the sham group, they will be given the choice to return for active stimulation.
Details
| Condition | Mild Cognitive Impairment, Cognitive Dysfunction, Memory Disorders in Old Age |
|---|---|
| Treatment | sham theta burst stimulation, Active Theta Burst Stimulation |
| Clinical Study Identifier | NCT04558164 |
| Sponsor | University of California, Los Angeles |
| Last Modified on | 13 April 2023 |
Eligibility
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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