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Effect of brain and spinal cord stimulation on limb recovery in complete spinal cord injury patients

A study to investigate neuromodulatory role of intermittent theta burst stimulation in complete spinal cord injured patients implanted with iron oxide nanoparticle

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047038
Enrollment
64
Registered
2022-11-04
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S341- Other and unspecified injury of lumbar and sacral spinal cord

Interventions

Intervention1: Transcranial Magnetic Stimulation: A non-invasive magnetic pulse will be applied on the scalp underlying leg area on motor homunculus for 3-5 mins for 5 consecutive days and twice a day

Sponsors

Department of Biotechnology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Complete spinal cord injury patient with ASIA impairment score A,complete motor and sensory loss below the level of injury

Exclusion criteria

Exclusion criteria: 1. Osteoporotic Fracture 2. History of neurological or orthopaedic disease related to spinal cord 3. Head injury 4. Ferromagnetic metallic implants close to the target stimulation area 5. Pacemaker 6. Cognitive impairment 7. Pregnancy 8. History/family history of seizures 9. Acute eczema/ bed shore under the target stimulation area An informed consent form will be filled by patients if they fit into the inclusion and exclusion criteria.

Design outcomes

Primary

MeasureTime frame
This is the first research based trial using nanotechnology with iTBS for inducing locomotor recovery and also assessing changes in cortical excitability and connectivity in Complete Spinal Cord Injury patients. The proposed intervention of iTBS along with implantation of hydrogel containing neurotrophic factors and IONPs, will augment the restoration of lost functions in complete SCI patients. We expect improvement in the functions below the level of lesion; autonomic functions like urinary and bowel control, locomotion, relief from pain, and psychological well-being.Timepoint: All assessments will be done before and after the intervention. follow-up assessments will be done at 1 month, 2 months and 3 months after the intervention.

Secondary

MeasureTime frame
This will improve the quality of life of patients and ease the burden on public health. We presume that this non-invasive, activity-dependent strategy would be able to reduce the etiology of the disease.Timepoint: All assessments will be done before and after the intervention. follow-up assessments will be done at 1 month, 2 months, and 3 months after the intervention.

Countries

India

Contacts

Public ContactDeeksha Patel

All India Institute of Medical Sciences, New Delhi

sumanjain10@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026