WalkingNCT00494689
Transcranial and Rapid Magnetic Stimulation for Gait Apraxia Due to Normal Pressure Hydrocephalus and Cerebral Ischemia
An observational study of Walking and Cognitive Function, run by Devathasan Neurology Practice Pte Ltd at 2 sites in Singapore.
Trial summary
The investigator(neurologist) has published a study in International Congress Series, in the 15th International Conference of Biomagnetism Vancouver Proceedings 2006,and Science Direct website, of 15 patients with brain ischemia and dilated ventricles who improve when treated with transcranial monitoring or low… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Walking, Cognitive Function
- How many people
- 30 participants
- Where
- 2 sitesSingapore
- Study dates
- Jan 2002to Jun 2007
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- cerebral ischemia with our without hydrocephalus and gait apraxia
Who cannot join
- all other conditions which contribute to walking difficulty e.g. bad knees; or spondylosis; parkinson's or paralytic strokes
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites, 2 recruiting
- Recruiting
Devathasan Neurology Practice #11-16 MEMC
Singapore, 228510
Devathasan Gobinathan, FRCP MD
- Recruiting
Devathasan Neurology Practice
Singapore, 228510
Gobinathan Devathasan, FRCP, 65-97304401, devathasan@msn.com
About this study
The investigator(neurologist) has published a study in International Congress Series, in the 15th International Conference of Biomagnetism Vancouver Proceedings 2006,and Science Direct website, of 15 patients with brain ischemia and dilated ventricles who improve when treated with transcranial monitoring or low ultrasound wave intensity (milliwatts) and with rapid magnetic stimulation which is also a diagnostic tool routinely used by many neurophysiologists. Before, these patients will progress and may need a brain shunt called Ventriculo-peritoneal shunt. He and collaborators now would like to do a double study as this appears to be a cheap and effective alternative treatment and help patients to walk again.
Read the detailed description
The transcranial monitoring intensity would be equivalent to the well known CLOTBUST study (<300mw/sq cm)for one hour, using two probes.
All will be treated as an outpatient and there is no form of infusion or interventional treatment.
The rapid magnetic stimulation is at about 50a/us, 15Hz, 1000 pulses with 10 sec pause for ten days along the skull vault. Informed consent will be obtained. 30 patients will be recruited and sham treatment would be just applying probe without power for transcranial and for magnetic stimulation coil will be angled away. Data will be compiled by a separate blinded investigator and so with the statistics. VP shunt failure patients, which is common, will be included. Barthel's daily living index and standard cognitive tests will be used to assess results.
- Conditions
- Walking, Cognitive Function
- Keywords
- transcranial sonolysis or monitoring, rapid magnetic stimulation, cerebral ischemia, hydrocephalus, Barthel's index
- Medical subject headings
- Brain Ischemia, Hydrocephalus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2007 (estimated)
- Study startJan 2002
- Study completionJun 2007 (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 WalkingStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Devathasan Neurology Practice Pte Ltd
- Sponsor type
- University, hospital or other
- Investigators
- Weng Kiong Aw Yong, Bsc (QUT), Study chair, Freelancer Computer Programmer and data control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494689
- Sponsor's protocol ID
- 02
- Status last verified
- Jun 2007
- First submitted
- 28 Jun 2007
- Last updated
- 2 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Devathasan G, Dinesh D. Rapid magnetic stimulation with sonolysis for gait apraxia due to to normal pressure hyprocephalus and cerebral ischemia. International Congress Series xx (2007)xxx-xxx( in press)
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial and Rapid Magnetic Stimulation for Gait Apraxia Due to Normal Pressure Hydrocephalus and Cerebral Ischemia
- ClinicalTrials.gov ID
- NCT00494689
- Acronym / sponsor ID
- 02
- Conditions
- Walking, Cognitive Function
- Keywords
- transcranial sonolysis or monitoring, rapid magnetic stimulation, cerebral ischemia, hydrocephalus, Barthel's index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Devathasan Neurology Practice Pte LtdUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- Jun 2007 (estimated)
- First posted
- 2 Jul 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.
The investigator(neurologist) has published a study in International Congress Series, in the 15th International Conference of Biomagnetism Vancouver Proceedings 2006,and Science Direct website, of 15 patients with brain ischemia and dilated ventricles who improve when treated with transcranial monitoring or low ultrasound wave intensity (milliwatts) and with rapid magnetic stimulation which is also a diagnostic tool routinely used by many neurophysiologists. Before, these patients will progress and may need a brain shunt called Ventriculo-peritoneal shunt. He and collaborators now would like to do a double study as this appears to be a cheap and effective alternative treatment and help patients to walk again.
Detailed description
The transcranial monitoring intensity would be equivalent to the well known CLOTBUST study (<300mw/sq cm)for one hour, using two probes.
All will be treated as an outpatient and there is no form of infusion or interventional treatment.
The rapid magnetic stimulation is at about 50a/us, 15Hz, 1000 pulses with 10 sec pause for ten days along the skull vault. Informed consent will be obtained. 30 patients will be recruited and sham treatment would be just applying probe without power for transcranial and for magnetic stimulation coil will be angled away. Data will be compiled by a separate blinded investigator and so with the statistics. VP shunt failure patients, which is common, will be included. Barthel's daily living index and standard cognitive tests will be used to assess results.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- cerebral ischemia with our without hydrocephalus and gait apraxia
Key exclusion criteria (1 listed)
- all other conditions which contribute to walking difficulty e.g. bad knees; or spondylosis; parkinson's or paralytic strokes
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2007.
- BackgroundDevathasan G, Dinesh D. Rapid magnetic stimulation with sonolysis for gait apraxia due to to normal pressure hyprocephalus and cerebral ischemia. International Congress Series xx (2007)xxx-xxx( in press)
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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.
Weng Kiong Aw Yong, Bsc (QUT) study chair
Freelancer Computer Programmer and data control
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Walking and Cognitive Function, run by Devathasan Neurology Practice Pte Ltd at 2 sites in Singapore.
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 1 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 2 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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 Devathasan Gobinathan, FRCP,MD (65-67330311, devathasan@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00494689, 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 2 Jul 2007; AzTrials last refreshed its copy on 7 Nov 2026.