Ignite Creation Date:
2024-05-06 @ 9:10 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02911129
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2016-09-21
Brief Title:
Effects of Prism Adaption and rTMS on Brain Connectivity and Visual Representation
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of Prism Adaption and rTMS on Brain Connectivity and Visual Representation
Status:
COMPLETED
Status Verified Date:
2024-03-18
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
After a stroke the balance between the two halves of the brain can be lost This may cause people to lose the ability to perceive a side of space This is called neglect Having people wear prism glasses called PA can reduce neglect symptoms Researchers want to find out more about how PA and whether it restores the balance in the brain
Objective
To learn how prism adaption temporarily changes vision and connections in the brain
Eligibility
People ages 18 75 with brain damage of the right side of the brain from a stroke or other cause leading to neglect
Healthy volunteers ages 18 75
Design
Participants will have 1 3 visits
Participants will be screened with a neurological exam They may also have
Tests of thinking and vision
Tests to see which eye and hand they prefer
A pregnancy test
All participants will
Answer questions about their personality style of thinking and beliefs
Do simple tasks on paper or computer
Have magnetic resonance imaging They will lie on a table that can slide in and out of a cylinder in a strong magnetic field Participants will lie still or do computer tasks in the scanner
Participants may also have
Transcranial magnetic stimulation A brief electrical current passes through a wire coil on the scalp This creates a magnetic pulse that affects brain activity Participants may be asked to tense certain muscles or perform simple actions or tasks
PA They will sit in front of a board and point to a dot on it while they wear prism glasses that shift vision to the left or right
After a stroke the balance between the two halves of the brain can be lost This may cause people to lose the ability to perceive a side of space This is called neglect Having people wear prism glasses called PA can reduce neglect symptoms Researchers want to find out more about how PA and whether it restores the balance in the brain
Objective
To learn how prism adaption temporarily changes vision and connections in the brain
Eligibility
People ages 18 75 with brain damage of the right side of the brain from a stroke or other cause leading to neglect
Healthy volunteers ages 18 75
Design
Participants will have 1 3 visits
Participants will be screened with a neurological exam They may also have
Tests of thinking and vision
Tests to see which eye and hand they prefer
A pregnancy test
All participants will
Answer questions about their personality style of thinking and beliefs
Do simple tasks on paper or computer
Have magnetic resonance imaging They will lie on a table that can slide in and out of a cylinder in a strong magnetic field Participants will lie still or do computer tasks in the scanner
Participants may also have
Transcranial magnetic stimulation A brief electrical current passes through a wire coil on the scalp This creates a magnetic pulse that affects brain activity Participants may be asked to tense certain muscles or perform simple actions or tasks
PA They will sit in front of a board and point to a dot on it while they wear prism glasses that shift vision to the left or right
Detailed Description:
OBJECTIVES
The ability to efficiently select information from the environment relies on a balanced interaction between the right and left hemispheres Hemispatial neglect most frequently following damage to the right hemisphere has been hypothesized to result from the breakdown of this interhemispheric balance There is evidence from transcranial stimulation studies that the breakdown of this interhemispheric balance is reflected in fronto-parietal connectivity The primary goal of this study is to test whether altering the balance between the left and right hemispheres with repetitive transcranial magnetic stimulation rTMS or prism adaptation PA will affect functional connectivity measured with functional magnetic resonance imaging fMRI We will also explore the relationship between the changes in functional connectivity and behavioral performances
STUDY POPULATION Healthy adult volunteers and patients with neglect after a right hemisphere damage
DESIGN The study contains three experiments Experiment 1 is designed to investigate the mechanism of the changes induced by PA in both resting state functional connectivity in neglect patients and healthy volunteers a two-arm parallel study Experiment 2 is designed to investigate the mechanism of the changes in resting state functional connectivity induced by lPA rPA nPA in healthy volunteers with right dominant eyes and lPA in healthy volunteer with left dominant eye a four-arm parallel study Experiment 3 is designed to see if inhibitory rTMS over the right posterior parietal cortex PPC can influence functional connectivity and visuospatial bias in healthy volunteers a crossover study
OUTCOME MEASURES For all three experiments the primary outcome measure is the change or difference in fronto-parietal resting state connectivity between post and pre PA or rTMS procedure The secondary outcome measures are the changes in visual field representation and in visuo-motor and cognitive behavior accompanying these manipulations
The ability to efficiently select information from the environment relies on a balanced interaction between the right and left hemispheres Hemispatial neglect most frequently following damage to the right hemisphere has been hypothesized to result from the breakdown of this interhemispheric balance There is evidence from transcranial stimulation studies that the breakdown of this interhemispheric balance is reflected in fronto-parietal connectivity The primary goal of this study is to test whether altering the balance between the left and right hemispheres with repetitive transcranial magnetic stimulation rTMS or prism adaptation PA will affect functional connectivity measured with functional magnetic resonance imaging fMRI We will also explore the relationship between the changes in functional connectivity and behavioral performances
STUDY POPULATION Healthy adult volunteers and patients with neglect after a right hemisphere damage
DESIGN The study contains three experiments Experiment 1 is designed to investigate the mechanism of the changes induced by PA in both resting state functional connectivity in neglect patients and healthy volunteers a two-arm parallel study Experiment 2 is designed to investigate the mechanism of the changes in resting state functional connectivity induced by lPA rPA nPA in healthy volunteers with right dominant eyes and lPA in healthy volunteer with left dominant eye a four-arm parallel study Experiment 3 is designed to see if inhibitory rTMS over the right posterior parietal cortex PPC can influence functional connectivity and visuospatial bias in healthy volunteers a crossover study
OUTCOME MEASURES For all three experiments the primary outcome measure is the change or difference in fronto-parietal resting state connectivity between post and pre PA or rTMS procedure The secondary outcome measures are the changes in visual field representation and in visuo-motor and cognitive behavior accompanying these manipulations
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 |
|---|---|---|---|
| 16-N-0170 | None | None | None |