Cytotron® Delivered Rotational Field Quantum Magnetic Resonance Therapy for Multiple Sclerosis

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2010/091/002827
• Date of registration: 20-10-2010
• Prospective Registration: No
• 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
• Phase: Phase 2

Countries of recruitment

India

Contacts

• Name: Dr Ranjit Kumar
• Affiliation: Scalene Cybernetics Ltd

• Name: Dr Anjana Nair
• 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

Health Condition 1: null- 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, end of therapy, 4 and 7 months post therapy.

Secondary ID(s)

NCT01220830

100915_CIP_MS_V1.0

Source(s) of Monetary Support

Scalene Cybernetics Ltd, S- Card Campus, Seegehalli Main Road, Virgonagar Post, Bangalore 560049, India Phone no: 08025614879/80

Ethics review

Status: Approved
Approval date: 23/01/2009
Contact:

Institutional Ethics Committee