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Non invasive brain stimulation to modulate impaired gait and bladder abnormalities in incomplete spinal cord injury patients

A randomized controlled trial to evaluate the effect of intermittent theta burst stimulation on gait pathomechanics and urinary tract dysfunction in incomplete spinal cord injury patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056150
Enrollment
60
Registered
2023-08-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Health Condition 1: G959- Disease of spinal cord, unspecified Health Condition 2: G998- Other specified disorders of nervous system in diseases classified elsewhere

Interventions

Intervention1: Non Invasive Neuromodulation Techniques: Intermittent theta burst stimulation on primary motor cortex (M1). Dose: 5 days per weeks for 2 weeks Control Intervention1: Physical Rehabilita

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Spinal cord Injury (ASIA C or D) Region: (Cervical C6 and C7), Thoracic and Lumbar Spine Duration : Type: Traumatic and Non-traumatic

Exclusion criteria

Exclusion criteria: Osteoporotic fractures, or other Pathological fractures. History of neurological or orthopaedic disease related to spinal cord. Congenital malformations (disorder of neuro lesions) pertaining to CNS or PNS. Cardiac Pacemaker, DBS, spinal cord stimulator, baclofen pump or any ferromagnetic metallic implants close to the target stimulation area. Ventilator dependent and tracheostomy patients. Cognitive impairments. Pregnancy. History/family history of seizures. Acute eczema/ bed sore under the target stimulation area.

Design outcomes

Primary

MeasureTime frame
Spatio- Temporal parameters of Gait (Walking speed, Stride length, Cadence etc)Timepoint: Baseline and 4 weeks after completion of the intervention

Secondary

MeasureTime frame
Urodynamic parameters (Detrusor leak point pressure, Detrusor sphincter dyssynergia, Incontinence abdominal leak point pressure, Post-void residual volume etc.). Electrophysiological parameters (Resting Motor Threshold, Active Motor Threshold, Motor Evoked Potential). Functional parameters (Walking index for SCI II, Spinal Cord Independence Measure III). Neurological parameters (ASIA impairment scale, Modified Ashworth Scale). Psycho-social parameters (Beck Depression Inventory, State Trait Anxiety Inventory II). Timepoint: Baseline and 4 weeks after completion of the intervention.

Countries

India

Contacts

Public ContactRohit Banerjee

All India Institute of Medical Sciences

rohitphysio@gmail.com6290276465

Outcome results

None listed

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