Acute Inflammatory Demyelinating PolyradiculoneuropathyNCT02722070
Processing Integration in Neurological Patients Using fMRI
An observational study of Acute Inflammatory Demyelinating Polyradiculoneuropathy and Stroke, run by Hadassah Medical Organization.
Trial summary
The main objective of the study is to explore and map brain areas involved in processing and perception in patients suffering from neurological pathologies and condition. The investigators hypothesize for example, that a change (compare to healthy subjects) in the perceptual maps and body representation could be… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Inflammatory Demyelinating Polyradiculoneuropathy, Stroke, Anosognosia
- What is being tested?
- 3 Tesla Siemens Skyra MRI scanner
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients suffering from central and peripheral neurological pathologies and conditions
Who may be able to join
- diagnosis of the investigated neuronal disease
Who cannot join
- contraindication for MRI scan
- pregnancy
- refusal to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
The main objective of the study is to explore and map brain areas involved in processing and perception in patients suffering from neurological pathologies and condition. The investigators hypothesize for example, that a change (compare to healthy subjects) in the perceptual maps and body representation could be detected and characterize in patients suffering from impairments of peripheral nerve conduction.
- Conditions
- Acute Inflammatory Demyelinating Polyradiculoneuropathy, Stroke, Anosognosia, Central and Peripheral Neurodegenerative Pathologies, Neuropsychiatric Conditions
- Being tested
- 3 Tesla Siemens Skyra MRI scanner
- Medical subject headings
- Guillain-Barre Syndrome, Stroke, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 Tesla Siemens Skyra MRI scannerDevice
Standardly used Magnetic resonance imaging (MRI) protocols, including resting state fMRI, task fMRI, T1 weighted imaging
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Age matched control for the various clinical groups Receives: Device: 3 Tesla Siemens Skyra MRI scanner | |
| Neurodegenerative patients | Not described Receives: Device: 3 Tesla Siemens Skyra MRI scanner | |
| Stroke patients | Not described Receives: Device: 3 Tesla Siemens Skyra MRI scanner | |
| Neuropsychiatric patients | Not described Receives: Device: 3 Tesla Siemens Skyra MRI scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic responses by measurement of the Blood-oxygen-level dependence(BOLD) signal
Distinct maps of sensory and multisensory representations related to certain disorders will be sassed by measurement of the Blood-oxygen-level dependence(BOLD) signal.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2020 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Inflammatory Demyelinating PolyradiculoneuropathyStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722070
- Sponsor's protocol ID
- 0657-15-HMO-CTIL
- Status last verified
- Jan 2016
- First submitted
- 23 Mar 2016
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Arzy S, Overney LS, Landis T, Blanke O. Neural mechanisms of embodiment: asomatognosia due to premotor cortex damage. Arch Neurol. 2006 Jul;63(7):1022-5. doi: 10.1001/archneur.63.7.1022.
PubMed 16831974
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Processing Integration in Neurological Patients Using fMRI
- ClinicalTrials.gov ID
- NCT02722070
- Acronym / sponsor ID
- 0657-15-HMO-CTIL
- Conditions
- Acute Inflammatory Demyelinating Polyradiculoneuropathy, Stroke, Anosognosia, Central and Peripheral Neurodegenerative Pathologies, Neuropsychiatric Conditions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 29 Mar 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.
The main objective of the study is to explore and map brain areas involved in processing and perception in patients suffering from neurological pathologies and condition. The investigators hypothesize for example, that a change (compare to healthy subjects) in the perceptual maps and body representation could be detected and characterize in patients suffering from impairments of peripheral nerve conduction.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Device: 3 Tesla Siemens Skyra MRI scannerAge matched control for the various clinical groups |
| Neurodegenerative patients | – | Device: 3 Tesla Siemens Skyra MRI scanner |
| Stroke patients | – | Device: 3 Tesla Siemens Skyra MRI scanner |
| Neuropsychiatric patients | – | Device: 3 Tesla Siemens Skyra MRI scanner |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from central and peripheral neurological pathologies and conditions
Key inclusion criteria (1 listed)
- diagnosis of the investigated neuronal disease
Key exclusion criteria (3 listed)
- contraindication for MRI scan
- pregnancy
- refusal to participate in the study
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 |
|---|---|---|
| 3 Tesla Siemens Skyra MRI scannerStandardly used Magnetic resonance imaging (MRI) protocols, including resting state fMRI, task fMRI, T1 weighted imaging | Device | Healthy Controls, Neurodegenerative patients, Neuropsychiatric patients, Stroke patients |
Primary outcome
Hemodynamic responses by measurement of the Blood-oxygen-level dependence(BOLD) signal
Time frame: 2 years
Distinct maps of sensory and multisensory representations related to certain disorders will be sassed by measurement of the Blood-oxygen-level dependence(BOLD) signal.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
- Results publication: PubMed 16831974Arzy S, Overney LS, Landis T, Blanke O. Neural mechanisms of embodiment: asomatognosia due to premotor cortex damage. Arch Neurol. 2006 Jul;63(7):1022-5. doi: 10.1001/archneur.63.7.1022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Inflammatory Demyelinating Polyradiculoneuropathy and Stroke, run by Hadassah Medical Organization.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahar Arzy, M.D, Ph.D (97226777741, shahar.arzy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic responses by measurement of the Blood-oxygen-level dependence(BOLD) signal (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02722070, which also lists 1 linked publication.
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 29 Mar 2016.