Normal PhysiologyNCT02911129
Effects of Prism Adaption and rTMS on Brain Connectivity and Visual Representation
An observational study of Normal Physiology and Stroke, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Physiology, Stroke
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2016to 24 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary Clinical
Who may be able to join
- All participants must have had a neurological examination by a NINDS physician within the last two years, a clinical MRI within the last year, and be able to read, write and speak English.
- Experiment 2 requires 63 healthy volunteers having right dominant eye and 21 volunteers having left dominant eye. Therefore, healthy volunteers with left dominant eye will be recruited until the necessary number is reached. We estimate we will have to screen 150
- healthy volunteers. Participants for whom the study was not completed due to technical problems and who did not undergo prism adaptation or TMS will be retested and data from the incomplete session will not be analyzed.
- A-Inclusion Criteria for Healthy volunteers/Age-matched Controls
- Experiment 1
- Age 18-75 (inclusive; we will try to match this to the stroke group)
Show all 20Show fewer
- Montreal Cognitive Assessment score greater than or equal to 26
- Absence of neglect at time of testing (Diller test score less than or equal to 2)
- Experiments 2 and 3
- Right-handedness
- Age 18-35 (inclusive)
- Twelve or more years of education
- Are able to see a dot of size 0.2 inches at a distance of 22.5 inches without glasses or with contact lenses (only for Experiment 2)
- B-Inclusion Criteria for Patients
- Experiment 1
- Age 18-75 (inclusive)
- Montreal Cognitive Assessment score greater than or equal to 26
- A right hemisphere stroke or other focal, non-progressive, brain lesion resulting in neglect
- Minimum of 30 days from lesion onset to testing
- Evidence of neglect at time of testing (Diller test score greater than or equal to 5)
Who cannot join
- A- Exclusion Criteria for Healthy volunteers
- Significant illness affecting the central nervous system
- History of seizure (for Experiment 3)
- Inability to give informed consent
- Concurrent use of sedating medications
- Trained to write in other than left to right direction
Show all 24Show fewer
- Ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, or ocular foreign body
- Implanted cardiac pacemaker or auto-defibrillator or pump
- Non-removable body piercing
- Claustrophobia
- Inability to lie supine for 1.5 hour
- Pregnancy
- Members of the NINDS Behavioral Neurology Unit (BNU)
- B- Exclusion Criteria for Patients and Age-matched Controls:
- Significant illness affecting the central nervous system, other than right hemisphere lesion causing neglect in patients
- Inability to give informed consent
- Concurrent use of sedating medications
- Ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, or ocular foreign body
- Implanted cardiac pacemaker or auto-defibrillator or pump
- Non-removable body piercing
- Claustrophobia
- Inability to lie supine for 1.5 hour
- Pregnancy
- Members of the NINDS Behavioral Neurology Unit (BNU)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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....
Read the 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.
- Conditions
- Normal Physiology, Stroke
- Keywords
- Chronic Stroke, Neglect, Transcranial Magnetic Stimulation, Visual and Motor Integration, Visual Fields, Natural History
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | Inclusion Criteria for Healthy Volunteers/Age-matched Controls | |
| Patients | Patients with neglect after a right hemisphere brain lesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiment 1: The primary outcome measure will be the change in the strength of the fronto-parietal resting state network (RSN) after rPA in neglect patients.
Measurement of Change
Measured: 1 week
Experiments 2: The primary outcome measure will be the change in the strength of the fronto-parietal resting state network (RSN) after rPA or lPA or nPA.
Measurement of change
Measured: 1 week
Experiment 3: The primary outcome measure will be the change in the strength of the fronto-parietal resting state network (RSN) after cTBS over the PPC versus cTBS over the vertex.
Measurement of change
Measured: 3 weeks
Secondary outcomes (3)
Experiment 1: The change of preferred center and size in the different region of interest (ROI) in the parietal cortex, and the change in open loop pointing task performances after rPA.
Observation of changeExperiment 1: The change of preferred center (visual field location) and size (visual field extent) (i.e. population receptive field) in the different region of interest (ROI) in the parietal cortex, and the change in open loop pointing task performances after rPA.
Measured: 1 week
Experiments 2: The change of preferred center and sizein the different region of interest (ROI) in the parietal cortex, and the change in open loop pointing task performances after rPA or lPA, or nPA
Observation of changeExperiments 2: The change of preferred center (visual field location) and size (visual field extent) (i.e. population receptive field) in the different region of interest (ROI) in the parietal cortex, and the change in open loop pointing task performances after rPA or lPA, or nPA
Measured: 1 week
Experiments 3: The change in perceptual line bisection performances after r cTBS over PPC or cTBS over the vertex.
Oberservation of change
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start4 Nov 2016
- Primary completion21 Dec 2018
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal PhysiologyStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Eric M Wassermann, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911129
- Sponsor's protocol ID
- 160170
- Other IDs
- 16-N-0170
- Status last verified
- Feb 2025
- First submitted
- 21 Sep 2016
- Last updated
- 27 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prism Adaption and rTMS on Brain Connectivity and Visual Representation
- ClinicalTrials.gov ID
- NCT02911129
- Acronym / sponsor ID
- 160170
- Conditions
- Normal Physiology, Stroke
- Keywords
- Chronic Stroke, Neglect, Transcranial Magnetic Stimulation, Visual and Motor Integration, Visual Fields, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 4 Nov 2016 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | – | –Inclusion Criteria for Healthy Volunteers/Age-matched Controls |
| Patients | – | –Patients with neglect after a right hemisphere brain lesion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Clinical
Key inclusion criteria (20 listed)
- All participants must have had a neurological examination by a NINDS physician within the last two years, a clinical MRI within the last year, and be able to read, write and speak English.
- Experiment 2 requires 63 healthy volunteers having right dominant eye and 21 volunteers having left dominant eye. Therefore, healthy volunteers with left dominant eye will be recruited until the necessary number is reached. We estimate we will have to screen 150
- healthy volunteers. Participants for whom the study was not completed due to technical problems and who did not undergo prism adaptation or TMS will be retested and data from the incomplete session will not be analyzed.
- A-Inclusion Criteria for Healthy volunteers/Age-matched Controls
- Experiment 1
Key exclusion criteria (24 listed)
- A- Exclusion Criteria for Healthy volunteers
- Significant illness affecting the central nervous system
- History of seizure (for Experiment 3)
- Inability to give informed consent
- Concurrent use of sedating medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Experiment 1: The primary outcome measure will be the change in the strength of the fronto-parietal resting state network (RSN) after rPA in neglect patients.
Time frame: 1 week
Measurement of Change
Experiments 2: The primary outcome measure will be the change in the strength of the fronto-parietal resting state network (RSN) after rPA or lPA or nPA.
Time frame: 1 week
Measurement of change
Experiment 3: The primary outcome measure will be the change in the strength of the fronto-parietal resting state network (RSN) after cTBS over the PPC versus cTBS over the vertex.
Time frame: 3 weeks
Measurement of change
3 secondary outcomes
Experiment 1: The change of preferred center and size in the different region of interest (ROI) in the parietal cortex, and the change in open loop pointing task performances after rPA.
Time frame: 1 week
Experiments 2: The change of preferred center and sizein the different region of interest (ROI) in the parietal cortex, and the change in open loop pointing task performances after rPA or lPA, or nPA
Time frame: 1 week
Experiments 3: The change in perceptual line bisection performances after r cTBS over PPC or cTBS over the vertex.
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric M Wassermann, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Physiology and Stroke, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiment 1: The primary outcome measure will be the change in the strength of the fronto-parietal resting state network (RSN) after rPA in neglect patients. (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.