HealthyNCT00418652
Interruption of Dorsal Visual Stream Using TMS
A study testing No TMS intervention, TMS over the PO3 EEG site and TMS over the vertex in people with Healthy, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Trans Cranial Magnetic Stimulation (TMS) over dorsal visual system will disturb the ability to identify objects with decreased level of fragmentation Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- No TMS intervention, TMS over the PO3 EEG site and TMS over the vertex
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2006to Jul 2010
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal controls
Who cannot join
- neurological, ophthalmological or psychiatric problems
- family history of schizophrenia
- left handed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interruption of Dorsal Visual Stream Using TMS in Normal Controls
Trans Cranial Magnetic Stimulation (TMS) over dorsal visual system will disturb the ability to identify objects with decreased level of fragmentation
Read the detailed description
The participants performed two tasks under three different TMS conditions: no TMS, 10Hz TMS for over the dorsal stream (PO3 EEG site) or over the vertex.
First they performed a perceptual closure task which asked them to identify an object in a series of six progressively less degraded pictures.
Then, they also performed a control task previously shown not to be mediated by the LOC and not to be impaired in schizophrenia: The perception of illusory contours.
- Conditions
- Healthy
- Being tested
- No TMS intervention, TMS over the PO3 EEG site, TMS over the vertex
- Keywords
- Normal Controls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No TMS interventionDevice
In the "no TMS" condition, no simulation was given and no coil placed near participants' heads.
TMS over the PO3 EEG siteDevice
Also called MAGSTIM biphasic stimulator
10Hz TMS over the dorsal stream (PO3 EEG site)
TMS over the vertexDevice
Also called MAGSTIM biphasic stimulator
10Hz TMS for over vertex.
| Study group | Role | What they receive |
|---|---|---|
| No TMS stimulation | No intervention | The patients performed 2 tasks: a study and a control assignments with no TMS stimulation. Receives: Device: No TMS intervention |
| TMS over the dorsal stream | Experimental | The patients performed 2 tasks: a study and a control assignments under TMS stimulation over the dorsal stream area (PO3 EEG site). Receives: Device: TMS over the PO3 EEG site |
| TMS over the vertex | Sham comparator | The patients performed 2 tasks: a study and a control assignments under TMS stimulation over the vertex area. Receives: Device: TMS over the vertex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of the study assignments performed by the participants during the study.
The subjects performed 2 tasks:
The primary dependent measures consisted of the level of detail needed for correct object identification, response accuracy, and response time in milliseconds for correct responses.
Illusory Contour Task: Subjects also performed a pulsed pedestal task, Participants were shown 55 drawings for 500 ms each. Some drawings contained partial contours which defined a geometric shape, while in others the contours did not define a shape. Participants were asked to indicate whether they recognized a geometric shape or not. Accuracy and response time were measured.
Measured: The participants performed the tasks once during their study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study startJan 2006
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Revital Amiaz, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418652
- Sponsor's protocol ID
- SHEBA-06-4252-RA-CTIL
- Status last verified
- Aug 2011
- First submitted
- 4 Jan 2007
- Last updated
- 4 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interruption of Dorsal Visual Stream Using TMS in Normal Controls
- ClinicalTrials.gov ID
- NCT00418652
- Acronym / sponsor ID
- SHEBA-06-4252-RA-CTIL
- Conditions
- Healthy
- Keywords
- Normal Controls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2006
- Primary completion
- Jul 2010 (actual)
- First posted
- 5 Jan 2007 (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.
Trans Cranial Magnetic Stimulation (TMS) over dorsal visual system will disturb the ability to identify objects with decreased level of fragmentation
Detailed description
The participants performed two tasks under three different TMS conditions: no TMS, 10Hz TMS for over the dorsal stream (PO3 EEG site) or over the vertex.
First they performed a perceptual closure task which asked them to identify an object in a series of six progressively less degraded pictures.
Then, they also performed a control task previously shown not to be mediated by the LOC and not to be impaired in schizophrenia: The perception of illusory contours.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No TMS stimulation | No intervention | Device: No TMS interventionThe patients performed 2 tasks: a study and a control assignments with no TMS stimulation. |
| TMS over the dorsal stream | Experimental | Device: TMS over the PO3 EEG siteThe patients performed 2 tasks: a study and a control assignments under TMS stimulation over the dorsal stream area (PO3 EEG site). |
| TMS over the vertex | Sham comparator | Device: TMS over the vertexThe patients performed 2 tasks: a study and a control assignments under TMS stimulation over the vertex area. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Normal controls
Key exclusion criteria (3 listed)
- neurological, ophthalmological or psychiatric problems
- family history of schizophrenia
- left handed
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 |
|---|---|---|
| No TMS interventionIn the "no TMS" condition, no simulation was given and no coil placed near participants' heads. | Device | No TMS stimulation |
| TMS over the PO3 EEG siteAlso: MAGSTIM biphasic stimulator10Hz TMS over the dorsal stream (PO3 EEG site) | Device | TMS over the dorsal stream |
| TMS over the vertexAlso: MAGSTIM biphasic stimulator10Hz TMS for over vertex. | Device | TMS over the vertex |
Primary outcome
Results of the study assignments performed by the participants during the study.
Time frame: The participants performed the tasks once during their study visit
The subjects performed 2 tasks: The primary dependent measures consisted of the level of detail needed for correct object identification, response accuracy, and response time in milliseconds for correct responses. Illusory Contour Task: Subjects also performed a pulsed pedestal task, Participants were shown 55 drawings for 500 ms each. Some drawings contained partial contours which defined a geometric shape, while in others the contours did not define a shape. Participants were asked to indicate whether they recognized a geometric shape or not. Accuracy and response time were measured.
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 Aug 2011.
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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.
Revital Amiaz, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No TMS intervention, TMS over the PO3 EEG site and TMS over the vertex in people with Healthy, run by Sheba Medical Center 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: finished, as of the sponsor's last update on 4 Aug 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. Some participants in this study may receive a placebo. 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?
Results of the study assignments performed by the participants during the study. (time frame: The participants performed the tasks once during their study visit). 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 4 Aug 2011.