Ignite Creation Date:
2024-05-06 @ 1:20 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03994120
Status:
COMPLETED
Last Update Posted:
2022-07-06
First Post:
2019-06-20
Brief Title:
Modulating the Hippocampal and Striatal Memory Networks With rTMS
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Modulating the Hippocampal and Striatal Memory Networks With rTMS
Status:
COMPLETED
Status Verified Date:
2021-05
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:
Background
People have 2 memory systems One helps them learn skills and the other helps them learn facts Repetitive transcranial magnetic stimulation rTMS uses electric currents to activate brain cells This can make small changes in how brain systems operate Researchers will use rTMS to change how memory systems work and to see if changing one system causes the other to change too This could help find ways to improve learning and memory in people with memory disorders
Objective
To learn how different memory systems work with each other
Eligibility
Healthy adults ages 18-40 who are not pregnant
Design
Potential participants will be screened with a neurological exam if they have not had one from NINDS in the past 2 years They may have urine tests
Eligible participants will have 5-10 visits at NIH Each visit will last 1-6 hours Visits 1-4 will each take place 1 day apart
At visit 1 participants will have an MRI and take memory tests For MRI they will lie on a table that slides in and out of a cylinder that takes pictures of their brain They will also have rTMS For rTMS a metal coil is held on their scalp Brief electrical currents pass through the coil
At visits 2 and 3 participants will have rTMS
At visit 4 participants will have an MRI and do memory tests
About a week later participants will have visit 5 They will have an MRI and do memory tests Participants may be asked to have more visits if any technical problems occur Participant involvement will last 2 weeks
People have 2 memory systems One helps them learn skills and the other helps them learn facts Repetitive transcranial magnetic stimulation rTMS uses electric currents to activate brain cells This can make small changes in how brain systems operate Researchers will use rTMS to change how memory systems work and to see if changing one system causes the other to change too This could help find ways to improve learning and memory in people with memory disorders
Objective
To learn how different memory systems work with each other
Eligibility
Healthy adults ages 18-40 who are not pregnant
Design
Potential participants will be screened with a neurological exam if they have not had one from NINDS in the past 2 years They may have urine tests
Eligible participants will have 5-10 visits at NIH Each visit will last 1-6 hours Visits 1-4 will each take place 1 day apart
At visit 1 participants will have an MRI and take memory tests For MRI they will lie on a table that slides in and out of a cylinder that takes pictures of their brain They will also have rTMS For rTMS a metal coil is held on their scalp Brief electrical currents pass through the coil
At visits 2 and 3 participants will have rTMS
At visit 4 participants will have an MRI and do memory tests
About a week later participants will have visit 5 They will have an MRI and do memory tests Participants may be asked to have more visits if any technical problems occur Participant involvement will last 2 weeks
Detailed Description:
Objective
The Behavioral Neurology Unit studies the human brain systems underlying learning and adaptation with the ultimate goal of finding interventions to make these processes more efficient We are interested in whether repetitive transcranial magnetic stimulation rTMS can alter functional connectivity FC and behavioral efficiency in two memory networks in the brain the hippocampal network which supports the storage and retrieval of recallable facts concepts and events and the striatal network which supports the storage and retrieval of skills and habits Additionally because these networks interact behaviorally and can interfere with each other an important question is whether neuromodulation of one network changes connectivity and efficiency in the other network Pilot data from our group suggest that exogenous stimulation of one network causes it to expand its range of FC and co-opt resources from the other which is a potential mechanism for the observed behavioral interaction This study is designed to test a whether rTMS- modulates within-network FC and memory supported by that network and b whether this also causes FC and behavioral changes in the other network
Study population Healthy Volunteers
Design
This study contains four between-subjects experiments and is a mixed interintra subject design Experiment 1 will use nominally excitatory stimulation targeting the hippocampal network to increase FC within the hippocampal network We also expect to increase FC between the hippocampal and striatal networks increased declarative memory and a possible decrease in procedural learning Experiment 2 will use excitatory stimulation targeted to the striatal network We expect this to cause stronger within- network FC in the striatal network increased FC between the hippocampus and the striatal network and concomitant behavioral effects Experiments 3 and 4 will be similar except that we will target nominally inhibitory stimulation to these networks and look for the inverse results FC will be measured under resting and task-activated conditions and active rTMS will be compared to vertex sham
Outcome measures
The primary outcome measure is the change in FC produced by rTMS within the targeted network Between-network FC changes and corresponding memory changes will be secondary outcomes Exploratory measures will include correlations between individual cognitive differences questionnaires and NIH Toolbox scores and our primary and secondary outcome measures
The Behavioral Neurology Unit studies the human brain systems underlying learning and adaptation with the ultimate goal of finding interventions to make these processes more efficient We are interested in whether repetitive transcranial magnetic stimulation rTMS can alter functional connectivity FC and behavioral efficiency in two memory networks in the brain the hippocampal network which supports the storage and retrieval of recallable facts concepts and events and the striatal network which supports the storage and retrieval of skills and habits Additionally because these networks interact behaviorally and can interfere with each other an important question is whether neuromodulation of one network changes connectivity and efficiency in the other network Pilot data from our group suggest that exogenous stimulation of one network causes it to expand its range of FC and co-opt resources from the other which is a potential mechanism for the observed behavioral interaction This study is designed to test a whether rTMS- modulates within-network FC and memory supported by that network and b whether this also causes FC and behavioral changes in the other network
Study population Healthy Volunteers
Design
This study contains four between-subjects experiments and is a mixed interintra subject design Experiment 1 will use nominally excitatory stimulation targeting the hippocampal network to increase FC within the hippocampal network We also expect to increase FC between the hippocampal and striatal networks increased declarative memory and a possible decrease in procedural learning Experiment 2 will use excitatory stimulation targeted to the striatal network We expect this to cause stronger within- network FC in the striatal network increased FC between the hippocampus and the striatal network and concomitant behavioral effects Experiments 3 and 4 will be similar except that we will target nominally inhibitory stimulation to these networks and look for the inverse results FC will be measured under resting and task-activated conditions and active rTMS will be compared to vertex sham
Outcome measures
The primary outcome measure is the change in FC produced by rTMS within the targeted network Between-network FC changes and corresponding memory changes will be secondary outcomes Exploratory measures will include correlations between individual cognitive differences questionnaires and NIH Toolbox scores and our primary and secondary outcome measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 19-N-0114 | None | None | None |