Ignite Creation Date:
2024-05-06 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03331796
Status:
COMPLETED
Last Update Posted:
2023-05-26
First Post:
2017-09-18
Brief Title:
Noninvasive Brain Stimulation for Mild Cognitive Impairment
Sponsor:
Palo Alto Veterans Institute for Research
Organization:
Palo Alto Veterans Institute for Research
Study Overview
Official Title:
Noninvasive Cortical Stimulation to Improve Memory in Mild Cognitive Impairment
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to test the efficacy of repetitive Transcranial Magnetic Stimulation rTMS as a treatment for Mild Cognitive Impairment MCI Participants will be randomly assigned to one of three treatment groups Group 1 Active Dorsolateral Prefrontal Cortex DLPFC rTMS Group 2 Active Lateral Parietal Cortex LPC rTMS and Group 3 Inactive rTMS Placebo control evenly split between each coil location Participation in the study takes approximately 7 ½ months-including a 2-to 4-week treatment phase 20 rTMS sessions and a 6-month follow-up phase
Detailed Description:
This study aims to test the efficacy of a non-pharmacological treatment for MCI that involves noninvasive brain stimulation NIBS Early studies in Alzheimers disease AD dementia patients have found that repetitive transcranial magnetic stimulation rTMS a form of NIBS improved global cognitive function and activities of daily living Given that in AD neuronal loss and synaptic dysfunction progress along brain networks the results of these early studies of brain stimulation suggest there is sufficient neuroplasticity in AD for efficacious effects of brain stimulation Of the very few rTMS studies in MCI that have been published the effect size appears to be moderately large However it is not clear whether the dorsolateral prefrontal cortex DLPFC the stimulation site used in the most of the prior MCIAD rTMS trials is the optimal site for achieving the most efficacious effects including effects on episodic memory Importantly when other investigators used rTMS to stimulate a lateral parietal cortical LPC site in healthy young adults significant effects of rTMS on memory were measureable weeks later Moreover functional connectivity of brain regions was selectively increased including the posterior cingulate cortex PCC a hub of brain networks that is affected in amnestic MCI
Because stimulation of the DLPFC and the LPC may each have distinct effects we designed this pilot trial to have two active rTMS treatment groups DLPFC and LPC A third group will receive inactive placebo rTMS to achieve a controlled randomized double-blind trial For each of the three groups stimulation will be bilateral based on effects achieved in the AD studies The primary hypothesis is that active rTMS to either site of stimulation will be superior to inactive placebo rTMS in improving memory Measures of change in functional connectivity will be computed to examine whether there is evidence that rTMS changes connectivity of the PCC with other regions of the brain In addition to looking at effects of rTMS on functional connectivity and cognition in relation to the cortical site stimulated genetic markers will be collected toward addressing heterogeneity of response To track the durability of rTMS effects on memory participants will be followed longer than in any prior study up to 6 months after the intervention If this study finds rTMS improves memory in older adults with MCI further clinical development of this non-pharmacological treatment could ultimately improve the lives of millions of older adults who have MCI and are at an increased risk of developing dementia
Because stimulation of the DLPFC and the LPC may each have distinct effects we designed this pilot trial to have two active rTMS treatment groups DLPFC and LPC A third group will receive inactive placebo rTMS to achieve a controlled randomized double-blind trial For each of the three groups stimulation will be bilateral based on effects achieved in the AD studies The primary hypothesis is that active rTMS to either site of stimulation will be superior to inactive placebo rTMS in improving memory Measures of change in functional connectivity will be computed to examine whether there is evidence that rTMS changes connectivity of the PCC with other regions of the brain In addition to looking at effects of rTMS on functional connectivity and cognition in relation to the cortical site stimulated genetic markers will be collected toward addressing heterogeneity of response To track the durability of rTMS effects on memory participants will be followed longer than in any prior study up to 6 months after the intervention If this study finds rTMS improves memory in older adults with MCI further clinical development of this non-pharmacological treatment could ultimately improve the lives of millions of older adults who have MCI and are at an increased risk of developing dementia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG055526 | NIH | None | httpsreporternihgovquickSearchR01AG055526 |