StrokeNCT01177462
Transformation of Somatosensory and Visual Coordinate Systems
An observational study of Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Manipulation of object is a multisensory experience that includes tactile motion between the object and the fingerpad, visual motion elicited by the motion the object and the movement of the hand, and the active motor commend to control upper limb and hand conformation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2011to Dec 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will recruit 40 normal healthy adult subjects (equal to and more than 18 years old); the exclusion criteria are subjects with brain pathology, peripheral neuropathy and limb amputation. We will also recruit 50 stroke patients, the including criteria are stroke patients with stable medical condition and being capable of receiving the evaluations. In this group, stroke patients with peripheral neuropathy, and unstable medical condition.
Who may be able to join
- stroke patients
- stable medical condition
- can cooperate in evaluation
Who cannot join
- peripheral neuropathy
- limb ambulation
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan County, Taiwan, 333
Yu-Cheng Pei, MD PhD, +886-3-3281200 ext. 3846, yspeii@adm.cgmh.org.tw
About this study
Official title: The Transformation of Coordinates Between Somatosensory and Visual Systems: a Neurophysiological Study
Manipulation of object is a multisensory experience that includes tactile motion between the object and the fingerpad, visual motion elicited by the motion the object and the movement of the hand, and the active motor commend to control upper limb and hand conformation. It remains to be determined how such a complex interaction between touch and vision could be achieved effortlessly. In the present study, we will investigate how the motion information is transformed between touch and vision using the most novel approaches in human psychophysics, neuropsychology and monkey neurophysiology. Specifically, we will present tactile motion on primate fingerpads using a recently developed ball stimulator with a design in which we vary the direction of motion with respect to the skin surface and also vary the hand conformation and position. This setup allows us to systematically sample the possible scenarios involving coordinate transformation between the somatosensory and visual systems in conditions that could occur in hand exploration and object manipulation in daily life. We will present these tactile stimuli on normal human subject as well as stroke patients such as patients with spatial hemineglect. Finally, we will record from macaque monkeys in cortical areas that are thought to underlie the transformation of coordinates, such as the primary somatosensory cortex and posterior parietal cortex. The results of the present study will contribute to the understanding of multisensory integration and the rehabilitation for patients with impaired use of spatial information.
- Conditions
- Stroke
- Keywords
- coordinate system, normal
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hemineglect stroke patients | Stroke patients with hemineglect | |
| Control stroke patients | Stroke patients without hemineglect | |
| Normal control | Normal subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived direction of tactile motion
Detail description for time frame of assessment:
(1) for stroke patients, the assessment will be performed "in average" 6 months after the onset of stroke (2) for normal subjects: assessment will be done when the subject is willing to participate (3) the subject might come to the lab more than once if the experiment can not be completed in one session
Assessment:
We present tactile motion using tactile stimulators to (1)different digits (2)different hand conformations and (3) different hand positions relative to the trunk
Measured: Once; specifically for stroke patients, 6 months after the onset of stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startMar 2011
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Cheng Pei, Chang Gung Memorial Hospital
- Investigators
- Yu-Cheng Pei, MD PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177462
- Sponsor's protocol ID
- CMRPG590021G
- Status last verified
- Sep 2013
- First submitted
- 29 Jul 2010
- Last updated
- 25 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Transformation of Coordinates Between Somatosensory and Visual Systems: a Neurophysiological Study
- ClinicalTrials.gov ID
- NCT01177462
- Acronym / sponsor ID
- CMRPG590021G
- Conditions
- Stroke
- Keywords
- coordinate system, normal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2014 (estimated)
- First posted
- 9 Aug 2010 (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.
Manipulation of object is a multisensory experience that includes tactile motion between the object and the fingerpad, visual motion elicited by the motion the object and the movement of the hand, and the active motor commend to control upper limb and hand conformation. It remains to be determined how such a complex interaction between touch and vision could be achieved effortlessly. In the present study, we will investigate how the motion information is transformed between touch and vision using the most novel approaches in human psychophysics, neuropsychology and monkey neurophysiology. Specifically, we will present tactile motion on primate fingerpads using a recently developed ball stimulator with a design in which we vary the direction of motion with respect to the skin surface and also vary the hand conformation and position. This setup allows us to systematically sample the possible scenarios involving coordinate transformation between the somatosensory and visual systems in conditions that could occur in hand exploration and object manipulation in daily life. We will present these tactile stimuli on normal human subject as well as stroke patients such as patients with spatial hemineglect. Finally, we will record from macaque monkeys in cortical areas that are thought to underlie the transformation of coordinates, such as the primary somatosensory cortex and posterior parietal cortex. The results of the present study will contribute to the understanding of multisensory integration and the rehabilitation for patients with impaired use of spatial information.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hemineglect stroke patients | – | –Stroke patients with hemineglect |
| Control stroke patients | – | –Stroke patients without hemineglect |
| Normal control | – | –Normal subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit 40 normal healthy adult subjects (equal to and more than 18 years old); the exclusion criteria are subjects with brain pathology, peripheral neuropathy and limb amputation. We will also recruit 50 stroke patients, the including criteria are stroke patients with stable medical condition and being capable of receiving the evaluations. In this group, stroke patients with peripheral neuropathy, and unstable medical condition.
Key inclusion criteria (3 listed)
- stroke patients
- stable medical condition
- can cooperate in evaluation
Key exclusion criteria (2 listed)
- peripheral neuropathy
- limb ambulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perceived direction of tactile motion
Time frame: Once; specifically for stroke patients, 6 months after the onset of stroke
Detail description for time frame of assessment: (1) for stroke patients, the assessment will be performed "in average" 6 months after the onset of stroke (2) for normal subjects: assessment will be done when the subject is willing to participate (3) the subject might come to the lab more than once if the experiment can not be completed in one session Assessment: We present tactile motion using tactile stimulators to (1)different digits (2)different hand conformations and (3) different hand positions relative to the trunk
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2013.
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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.
Yu-Cheng Pei, MD PhD principal investigator
Chang Gung Memorial Hospital
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 Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 2 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 25 Sep 2013. 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 Taiwan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived direction of tactile motion (time frame: Once; specifically for stroke patients, 6 months after the onset of stroke). 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 25 Sep 2013.