Age-associated Memory Impairment Clinical Trial
Official title:
Task Paired Transcranial Magnetic Stimulation for Working Memory Potentiation
Verified date | May 2023 |
Source | Shirley Ryan AbilityLab |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to investigate the effects of Transcranial Magnetic Stimulation (TMS) following a Paired Associative Stimulation (PAS) protocol on the memorization capacity of elderly individuals. For this purpose, we will apply TMS synchronized with a working memory (WM) task and assess its effects on cortical connectivity and memorization capacity by Magnetic Resonance Imaging (MRI) and WM task learning. This study will be carried out in an older population of healthy participants. We will use the study results to refine the task related PAS protocol towards enhancing memory performance and brain connectivity.
Status | Terminated |
Enrollment | 1 |
Est. completion date | April 3, 2023 |
Est. primary completion date | April 3, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 85 Years |
Eligibility | Inclusion Criteria for Older Healthy Participants: - Age from 60 to 85 years, inclusive (For piloting purposes, this inclusion criteria may vary). - No history of a brain and/or skull lesion (e.g., stroke) - Normal vision (can be corrected) - Able to understand and give informed consent - No neurological disorders - Able to understand and speak English Exclusion Criteria for Healthy Participants: - Cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps - Metal in the body (rods, plates, screws, shrapnel, dentures, IUD) or metallic particles in the eye - Surgical clips in the head or previous neurosurgery - Any magnetic particles in the body - Cochlear implants - Prosthetic heart valves - Epilepsy or any other type of seizure history - History of significant head trauma (i.e., extended loss of consciousness, neurological sequelae) - Significant claustrophobia - Ménière's disease - Pregnancy or breast feeding - Non prescribed drug use - History of current substance abuse (exception: current nicotine use is allowed) - Marijuana - Any neurological diagnoses - Dementia; severe depression; or prior neurosurgical procedures - Tremor or parkinsonism, or psychiatric disease that would interfere with study procedures for TMS, or MRI. - Significant other disease (cardiological or heart disease, renal, hepatic, malignant tumors, mental or psychiatric disorders) that would prevent participants from fully engaging in study procedures - Prisoners - Medications contraindicated for TMS: antipsychotic and antidepressant medications. |
Country | Name | City | State |
---|---|---|---|
United States | Shirley Ryan AbilityLab | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Shirley Ryan AbilityLab |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Working Memory (WM) capacity | The WM task utilized is a customized version of the masking task model, presented by Sana Inoue and Tetsuro Matsuzawa, in 2007. This task is organized in three phases: 1) Waiting phase: a visual cue is presented to indicate the initiation of the trial; 2) Coding and retention phase: numbers are presented in a random arrangement within a 5x5 square matrix; and 3) Recall phase: the numbers disappear, leaving a white background as a clue, and the subject completes the task by pressing the squares in the matrix following the incremental order of the numbers. (Figure 2). The task ends either when the subject makes a mistake or completes correctly selecting all numbers in incremental order. The outcome measure for WM capacity is the amount of correctly remembered items (hit items) of each trial. | Compared during each visit between baseline, immediately after the intervention, and 30 minutes after intervention | |
Primary | Changes in resting state functional MRI connectivity | The neural connectivity index that we will assess responds to the strength of synaptic connections between neurons and over time. The identification of correlations between remote brain areas will be tested by resting state functional magnetic resonance imaging (rs-fMRI). We will compare the connectivity network after intervention time with baseline and sham group. Correlations of spontaneous modulations in the blood oxygen level dependent (BOLD) signal will be analyzed and regions with similar functional properties under resting conditions will be detected. This analysis is able to identify significant long-lasting effects of active stimulation (vs. sham) on brain connectivity. | Compared during each visit between baseline and 30 minutes after intervention |
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