BlindnessNCT00001926
The Connection Between Areas in the Brain of Blind Patients
An observational study of Blindness and Brain Mapping, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
The purpose of this study is to test the belief that specific areas of the brain are connected differently in blind patients than patients with sight. In addition, the study will examine the different anatomical connections between brain areas of patients who became blind early in life versus patients who became blind… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Blindness, Brain Mapping, Healthy
- What is being tested?
- O15 and Cadwell rTMS
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1999to Nov 2003
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects with late blindness.
- Subjects with early blindness.
- Sighted volunteers.
- Age between 18 and 65 years.
Who cannot join
- Subjects with personal or family history of seizures or other neurological or demyelinating disorders.
- Pregnant women tested after urine pregnancy test.
- Subjects with metal in the cranium except mouth.
- Subjects with intracardiac lines and implanted medication pumps.
- Subjects with increased intracranial pressure as evaluated by clinical means.
- Subjects with cardiac pacemakers.
- Intake or neuroleptics.
- Subjects with blindness secondary to degenerative CNS diseases.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Connectivity of Occipital and Somatosensory Cortical Areas in Blind Subjects
The purpose of this study is to test the belief that specific areas of the brain are connected differently in blind patients than patients with sight. In addition, the study will examine the different anatomical connections between brain areas of patients who became blind early in life versus patients who became blind later.
Read the detailed description
The purpose of this protocol is to test the hypothesis that the anatomical connectivity of occipital and somatosensory areas in early blind subjects differs from that in subjects who became blind later in life and from that in sighted volunteers.
- Conditions
- Blindness, Brain Mapping, Healthy
- Being tested
- O15, Cadwell rTMS
- Keywords
- Plasticity, Magnetic Stimulation, PET, Blind, Braille, Transcranial Magnetic Stimulation
- Medical subject headings
- Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O15Drug
Cadwell rTMSDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startApr 1999
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BlindnessStudies 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
- Enrolment
- 45 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001926
- Sponsor's protocol ID
- 990031
- Other IDs
- 99-N-0031
- Status last verified
- Nov 2003
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Cohen LG, Bandinelli S, Findley TW, Hallett M. Motor reorganization after upper limb amputation in man. A study with focal magnetic stimulation. Brain. 1991 Feb;114 ( Pt 1B):615-27. doi: 10.1093/brain/114.1.615.
PubMed 2004259Fuhr P, Cohen LG, Dang N, Findley TW, Haghighi S, Oro J, Hallett M. Physiological analysis of motor reorganization following lower limb amputation. Electroencephalogr Clin Neurophysiol. 1992 Feb;85(1):53-60. doi: 10.1016/0168-5597(92)90102-h.
PubMed 1371745Kew JJ, Ridding MC, Rothwell JC, Passingham RE, Leigh PN, Sooriakumaran S, Frackowiak RS, Brooks DJ. Reorganization of cortical blood flow and transcranial magnetic stimulation maps in human subjects after upper limb amputation. J Neurophysiol. 1994 Nov;72(5):2517-24. doi: 10.1152/jn.1994.72.5.2517.
PubMed 7884476
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connectivity of Occipital and Somatosensory Cortical Areas in Blind Subjects
- ClinicalTrials.gov ID
- NCT00001926
- Acronym / sponsor ID
- 990031
- Conditions
- Blindness, Brain Mapping, Healthy
- Keywords
- Plasticity, Magnetic Stimulation, PET, Blind, Braille, Transcranial Magnetic Stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Apr 1999
- Study completion
- Nov 2003
- First posted
- 4 Nov 1999 (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.
The purpose of this study is to test the belief that specific areas of the brain are connected differently in blind patients than patients with sight. In addition, the study will examine the different anatomical connections between brain areas of patients who became blind early in life versus patients who became blind later.
Detailed description
The purpose of this protocol is to test the hypothesis that the anatomical connectivity of occipital and somatosensory areas in early blind subjects differs from that in subjects who became blind later in life and from that in sighted volunteers.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with late blindness.
- Subjects with early blindness.
- Sighted volunteers.
- Age between 18 and 65 years.
Key exclusion criteria (8 listed)
- Subjects with personal or family history of seizures or other neurological or demyelinating disorders.
- Pregnant women tested after urine pregnancy test.
- Subjects with metal in the cranium except mouth.
- Subjects with intracardiac lines and implanted medication pumps.
- Subjects with increased intracranial pressure as evaluated by clinical means.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| O15 | Drug | – |
| Cadwell rTMS | Device | – |
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 2004259Cohen LG, Bandinelli S, Findley TW, Hallett M. Motor reorganization after upper limb amputation in man. A study with focal magnetic stimulation. Brain. 1991 Feb;114 ( Pt 1B):615-27. doi: 10.1093/brain/114.1.615.
- Background: PubMed 1371745Fuhr P, Cohen LG, Dang N, Findley TW, Haghighi S, Oro J, Hallett M. Physiological analysis of motor reorganization following lower limb amputation. Electroencephalogr Clin Neurophysiol. 1992 Feb;85(1):53-60. doi: 10.1016/0168-5597(92)90102-h.
- Background: PubMed 7884476Kew JJ, Ridding MC, Rothwell JC, Passingham RE, Leigh PN, Sooriakumaran S, Frackowiak RS, Brooks DJ. Reorganization of cortical blood flow and transcranial magnetic stimulation maps in human subjects after upper limb amputation. J Neurophysiol. 1994 Nov;72(5):2517-24. doi: 10.1152/jn.1994.72.5.2517.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Blindness and Brain Mapping, 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 4 inclusion and 8 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 4 Mar 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001926, which also lists 3 linked publications.
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 4 Mar 2008.