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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 31 March 2014
Main ID:  CTRI/2010/091/002827
Date of registration: 20-10-2010
Primary sponsor: Scalene Cybernetics Ltd
Public title: Cytotron® Delivered Rotational Field Quantum Magnetic Resonance Therapy for Multiple Sclerosis
Scientific title: Efficacy of Rotational Field Quantum Magnetic Resonance (RFQMR) Based Tissue Engineering in the Treatment of Multiple Sclerosis
Date of first enrolment: 05-10-2010
Target sample size: 40
Recruitment status: Suspended
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2311
Study type:  Interventional
Study design:  Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
 
Countries of recruitment
India
Contacts
Name: Dr Anjana Nair 
Address:  Centre for Advanced Research and Development, S-Card Campus Seegehalli Main Road, Virgonagar Post 560049 Bangalore, KARNATAKA India
Telephone: 08025614879
Email: ranjit1512@scalene.org
Affiliation:  Scalene Cybernetics Ltd
Name: Dr Ranjit Kumar 
Address:  Centre for Advanced Research and Development, S-Card Campus, Seegehalli Main Road Seegehalli Main Road, Virgonagar Post 560049 Bangalore, KARNATAKA India
Telephone: 08025614879
Email: ranjit1512@scalene.org
Affiliation:  Scalene Cybernetics Ltd
Key inclusion & exclusion criteria
Inclusion criteria: Male and female patients with clinically definite MS according to Polman



1. EDSS 0 to 7.

2. Relapse-free > 30 days prior to inclusion.

3. Stable immunomodulatory or immunosuppressive therapy or treatment for > 3 months prior to inclusion.

4. In case of treatment with antidepressants: stable

therapy > 3 months prior to inclusion.

5. Highly effective methods of birth control

for females.


Exclusion criteria: 1. Pregnancy
2. Cardiac pacemakers, biostimulators, neurostimulators,
cochlear implants, hearing aids.
3. MRI incompatible implants like intramedullary nails, intracranial aneurysm clips, intra-orbital metal
fragments, stents, implanted medication pumps
etc near target area.
4. Critically ill patients needing life support
system.
5. Mentally challenged patients who cannot give
informed consent.
6. Severely ill patients who cannot lie in supine
position for 1 hour.
7. H/o brain injury and/ or any malignant disorder
8. Personal or family history of epilepsy /
brain tumor.
9. Relapse of MS < 30 days prior to inclusion
10. Change of immunomodulatory therapy < 30 days
prior to inclusion
11. Bipolar disorder
12. History of stroke or other brain lesions


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Multiple Sclerosis
Intervention(s)
Intervention1: Rotational Field Quantum Magnetic Resonance (RFQMR) Therapy: Exposure to RFQMR with Cytotron® for 28 consecutive days for one hour daily.
Control Intervention1: NIL: NIL
Primary Outcome(s)
Effect of RFQMR therapy on MS lesions as revealed by Magnetic Resonance Imaging (MRI)



1.Change in number of T1 gadolinium- enhancing lesions with Magnetisation Transfer Ratio (MTR) on MRI.



2.Change in number of lesions on FLAIR MRI images.



3.Change in volume of brain and spinal lesions.Timepoint: Baseline, 4 and 7 months post therapy.
Secondary Outcome(s)
Effect of RFQMR therapy on disability status and quality of life of MS patients.



1.Change in Extended Disability Status Score (EDSS)



2.Change in Functional Assessment for Multiple sclerosis (FAMS) score.Timepoint: Baseline, 4 and 7 months post therapy.
Secondary ID(s)
100915_CIP_MS_V1.0
NCT01220830
Source(s) of Monetary Support
Scalene Cybernetics Ltd, S- Card Campus, Seegehalli Main Road, Virgonagar Post, Bangalore 560049, India Phone no: 08025614879/80
Secondary Sponsor(s)
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