Status:
UNKNOWN
Cytotron® Delivered Rotational Field Quantum Nuclear Magnetic Resonance Therapy for Multiple Sclerosis
Lead Sponsor:
The Centre for Advanced Research & Development, India
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the efficacy of RFQMR therapy in remyelination in cases of Multiple sclerosis. The evaluation will be done based on MRI findings, by clinical/ neurological exa...
Detailed Description
Transmembrane Potential (TMP) is one of the known cellular signalling pathways regulating synthesis of various proteins like those responsible for programmed cell death (e.g., p53 group) at the approp...
Eligibility Criteria
Inclusion
- Male and female patients with clinically definite MS according to Polman
- Age 18 to 60 yrs.
- EDSS 0 to 7.
- Relapse-free \> 30 days prior to inclusion.
- Stable immunomodulatory or immunosuppressive. therapy or treatment for \> 3 months prior to inclusion.
- In case of treatment with antidepressants:
- stable therapy \> 3 months prior to inclusion.
- Highly effective methods of birth control for females.
Exclusion
- Pregnancy
- Cardiac pacemakers, biostimulators, neurostimulators, cochlear implants, hearing aids.
- MRI incompatible implants like intramedullary nails, intracranial aneurysm clips, intra-orbital metal fragments, stents, implanted medication pumps etc near target area.
- Critically ill patients needing life support system.
- Mentally challenged patients who cannot give informed consent.
- Severely ill patients who cannot lie in supine position for 1 hour.
- H/o brain injury and/ or any malignant disorder
- Personal or family history of epilepsy / brain tumor.
- Relapse of MS \< 30 days prior to inclusion
- Change of immunomodulatory therapy \< 30 days prior to inclusion
- Bipolar disorder
- History of stroke or other brain lesions
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01220830
Start Date
September 1 2010
End Date
December 1 2011
Last Update
September 19 2011
Active Locations (1)
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1
Centre for Advanced Research and Development
Bangalore, Karnataka, India, 560 049