Acute Inflammatory Demyelinating PolyradiculoneuropathyNCT01469858
Perception and Multisensory Integration in Neurological Patients Using fMRI
A study testing Siemens magnetom avanto1.5 Tesla, Siemens magnetom trio A Tim system 3 Tesla in people with Acute Inflammatory Demyelinating Polyradiculoneuropathy and Myasthenia Gravis, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The main objective of the study is to explore and map brain areas involved in sensory perception and multisensory integration in patients with central or peripheral neurological damage. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Inflammatory Demyelinating Polyradiculoneuropathy, Myasthenia Gravis, Stroke
- What is being tested?
- Siemens magnetom avanto1.5 Tesla, Siemens magnetom trio A Tim system 3 Tesla
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2011to Nov 2015
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem
Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
The main objective of the study is to explore and map brain areas involved in sensory perception and multisensory integration in patients with central or peripheral neurological damage. 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, Myasthenia Gravis, Stroke, Anosognosia, Asomatognosia
- Being tested
- Siemens magnetom avanto1.5 Tesla, Siemens magnetom trio A Tim system 3 Tesla
- Medical subject headings
- Guillain-Barre Syndrome, Myasthenia Gravis, Stroke, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Siemens magnetom avanto1.5 Tesla, Siemens magnetom trio A Tim system 3 TeslaDevice
functional magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | fMRI Receives: Device: Siemens magnetom avanto1.5 Tesla, Siemens magnetom trio A Tim system 3 Tesla |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessing 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 assed by measurement of the Blood-oxygen-level dependence(BOLD)signal.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2013 (estimated)
- Study completionNov 2015 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT01469858
- Sponsor's protocol ID
- 044811HMO
- Status last verified
- Sep 2011
- First submitted
- 1 Nov 2011
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- 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 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception and Multisensory Integration in Neurological Patients Using fMRI
- ClinicalTrials.gov ID
- NCT01469858
- Acronym / sponsor ID
- 044811HMO
- Conditions
- Acute Inflammatory Demyelinating Polyradiculoneuropathy, Myasthenia Gravis, Stroke, Anosognosia, Asomatognosia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 10 Nov 2011 (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 sensory perception and multisensory integration in patients with central or peripheral neurological damage. 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: Siemens magnetom avanto1.5 Tesla, Siemens magnetom trio A Tim system 3 TeslafMRI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Siemens magnetom avanto1.5 Tesla, Siemens magnetom trio A Tim system 3 Teslafunctional magnetic resonance imaging | Device | study group |
Primary outcome
assessing hemodynamic responses by measurement of the Blood-oxygen-level dependence(BOLD)signal
Time frame: 1 year
Distinct maps of sensory and multisensory representations related to certain disorders will be assed 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 10 Nov 2011.
- Background: 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Siemens magnetom avanto1.5 Tesla, Siemens magnetom trio A Tim system 3 Tesla in people with Acute Inflammatory Demyelinating Polyradiculoneuropathy and Myasthenia Gravis, run by Hadassah Medical Organization at 1 site in Israel.
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 10 Nov 2011. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahar Arzi, MD PhD (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?
assessing hemodynamic responses by measurement of the Blood-oxygen-level dependence(BOLD)signal (time frame: 1 year). 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 NCT01469858, 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 10 Nov 2011.