Network-targeted Theta-burst Stimulation for Episodic Memory Improvement in Mild Cognitive Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-100
SponsorUniversity of California, Los Angeles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Agreement to participate in the study
55-100 years of age
Right-handedness
In good general health
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Active Theta Burst Stimulation
DeviceTheta burst transcranial magnetic stimulation (TBS) will be delivered at 80-100% of motor threshold (MT).
Sham Theta Burst Stimulation
DeviceSham stimulation will be delivered at 0-10% of motor threshold (MT), with all other parameters matching the active TBS condition.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Active TBSExperimental treatment 1 intervention
Group B: Sham TBSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20.2
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.
Time frame
Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20.3
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.
Time frame
Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20.Secondary outcomes
1
Resting state fMRI functional connectivity
Resting state fMRI activity will be measured before the first and after the last TBS treatment
Time frame
Baseline (Day 2) before the first treatment and after the last treatment (Day 17)2
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
Time frame
During treatment (Days 3, 7 and 12), after the last treatment (Day 17), and 2 month follow-up session (Day 20)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov