NCT02911129Completed
Effects of Prism Adaption and rTMS on Brain Connectivity and Visual Representation
Source: ClinicalTrials.gov · Last updated 27 Feb 2025
Brief summary (registry, in English)
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....
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 74 (actual)
- First submitted
- 21 Sept 2016
- Start date
- 4 Nov 2016
- Primary completion date
- 21 Dec 2018
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Diseases
- Stroke
- NCT number
- NCT02911129
What you commit to
- Study type: Observational
- Participants enrolled: 74
- From 4 Nov 2016 to the primary completion date, 21 Dec 2018
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- Significant illness affecting the central nervous system
- History of seizure (for Experiment 3)
- Implanted cardiac pacemaker or auto-defibrillator or pump
- Significant illness affecting the central nervous system, other than right hemisphere lesion causing neglect in patients
- Implanted cardiac pacemaker or auto-defibrillator or pump
Age
- Members of the NINDS Behavioral Neurology Unit (BNU)
- B- Exclusion Criteria for Patients and Age-matched Controls:
Other
- A- Exclusion Criteria for Healthy volunteers
- Inability to give informed consent
- Trained to write in other than left to right direction
- Non-removable body piercing
- Claustrophobia
- Inability to lie supine for 1.5 hour
- Pregnancy
- Inability to give informed consent
- Non-removable body piercing
- Claustrophobia
- Inability to lie supine for 1.5 hour
- Pregnancy
- Members of the NINDS Behavioral Neurology Unit (BNU)
Who the study is looking for
- 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)
- 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)
Criteria the registry did not label
- INCLUSION CRITERIA:
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.