Ignite Creation Date:
2024-05-06 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03434093
Status:
WITHDRAWN
Last Update Posted:
2019-02-28
First Post:
2018-02-14
Brief Title:
Modulation of the Parieto-frontal Communication
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Modulation of the Parieto-frontal Communication
Status:
WITHDRAWN
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator left NIH
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Research shows that the parietal and prefrontal areas of the brain are involved in short-term memory Researchers want to look at the effects of transcranial magnetic stimulation TMS of these areas on short-term memory and brain activity They will use functional magnetic resonance imaging fMRI to look at brain activity
Objective
To look at the effects of TMS on brain pathways involved in memory
Eligibility
Healthy right-handed adults ages 18-50
Design
Participants will have 3 or 4 visits at least 1 week apart They cannot drink alcohol for at least 48 hours before each visit
The screening visit lasts about 1 Omega hours It can be combined with the first testing visit Screening includes
Medical history
Physical exam
Neurological exam
Urine tests
Questionnaires about being left or right handed and about their ability to imagine physical activities
The first testing visit lasts about 1 Omega hours and includes an MRI For the MRI participants lie on a table that slides into a machine They will lie still or perform simple memory tasks on a computer screen
The second and third testing visits last about 3 hours Participants will have
2 MRIs
TMS A wire coil is held to the scalp A brief electrical current passes through the coil to create a magnetic pulse that affects brain activity They will perform simple memory tasks
EMG Small electrodes are taped to the skin to record muscle activity while they rest
After the study participants will complete a questionnaire about any discomfort they experienced during the study
Research shows that the parietal and prefrontal areas of the brain are involved in short-term memory Researchers want to look at the effects of transcranial magnetic stimulation TMS of these areas on short-term memory and brain activity They will use functional magnetic resonance imaging fMRI to look at brain activity
Objective
To look at the effects of TMS on brain pathways involved in memory
Eligibility
Healthy right-handed adults ages 18-50
Design
Participants will have 3 or 4 visits at least 1 week apart They cannot drink alcohol for at least 48 hours before each visit
The screening visit lasts about 1 Omega hours It can be combined with the first testing visit Screening includes
Medical history
Physical exam
Neurological exam
Urine tests
Questionnaires about being left or right handed and about their ability to imagine physical activities
The first testing visit lasts about 1 Omega hours and includes an MRI For the MRI participants lie on a table that slides into a machine They will lie still or perform simple memory tasks on a computer screen
The second and third testing visits last about 3 hours Participants will have
2 MRIs
TMS A wire coil is held to the scalp A brief electrical current passes through the coil to create a magnetic pulse that affects brain activity They will perform simple memory tasks
EMG Small electrodes are taped to the skin to record muscle activity while they rest
After the study participants will complete a questionnaire about any discomfort they experienced during the study
Detailed Description:
Objective This study aims to identify whether repetitive dual-site transcranial magnetic stimulation TMS can modulate the functional connectivity between the parietal and dorso-lateral prefrontal cortices
Study population The study involves 26 healthy volunteers
Design This controlled study comprises 3 main visits for each subject 1 a baseline evaluation visit during which fMRI will be acquired during a visual short memory task along with diffusion tensor imaging and structural MRI 2 a visit during which resting state fMRI rsfMRI will be acquired followed by paired-associative stimulation PAS with pulses delivered over the parietal and then over the dorso-lateral prefrontal cortex in order to induce a temporary plastic change in the interaction between the parietal and prefrontal cortices the PAS will be followed by another rsfMRI and task fMRI 3 a visit identical to 2 during which the PAS will be delivered with pulses in reverse order of previous visit
Outcome measures The effects of PAS will be quantified with rsfMRI and a short working memory task considered as a proxy for complex motor and cognitive control
The primary outcome will be to investigate the resting state functional connectivity changes induced by each PAS intervention
The secondary outcome 1 will be to evaluate the difference in visual angle error between sessions 2 and 3 in a working memory task during which the subjects will be asked to remember the position of a bar presented on the screen at different time intervals before the inquiry
The secondary outcome 2 will be to build an fMRI-DTI analysis pipeline for generation of TMS targets individually customized for each subject and a given task
Study population The study involves 26 healthy volunteers
Design This controlled study comprises 3 main visits for each subject 1 a baseline evaluation visit during which fMRI will be acquired during a visual short memory task along with diffusion tensor imaging and structural MRI 2 a visit during which resting state fMRI rsfMRI will be acquired followed by paired-associative stimulation PAS with pulses delivered over the parietal and then over the dorso-lateral prefrontal cortex in order to induce a temporary plastic change in the interaction between the parietal and prefrontal cortices the PAS will be followed by another rsfMRI and task fMRI 3 a visit identical to 2 during which the PAS will be delivered with pulses in reverse order of previous visit
Outcome measures The effects of PAS will be quantified with rsfMRI and a short working memory task considered as a proxy for complex motor and cognitive control
The primary outcome will be to investigate the resting state functional connectivity changes induced by each PAS intervention
The secondary outcome 1 will be to evaluate the difference in visual angle error between sessions 2 and 3 in a working memory task during which the subjects will be asked to remember the position of a bar presented on the screen at different time intervals before the inquiry
The secondary outcome 2 will be to build an fMRI-DTI analysis pipeline for generation of TMS targets individually customized for each subject and a given task
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 |
|---|---|---|---|
| 18-N-0054 | None | None | None |