on invasive brain stimulation to modulate impaired gait and bladder abnormalities in incomplete spinal cord injury patients
Not Applicable
- Conditions
- Health Condition 1: G959- Disease of spinal cord, unspecifiedHealth Condition 2: G998- Other specified disorders of nervous system in diseases classified elsewhere
- Registration Number
- CTRI/2023/08/056150
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Spinal cord Injury (ASIA C or D)
Region: (Cervical C6 and C7), Thoracic and Lumbar Spine
Duration : <= 2 years
Type: Traumatic and Non-traumatic
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Spatio- Temporal parameters of Gait (Walking speed, Stride length, Cadence etc)Timepoint: Baseline and 4 weeks after completion of the intervention
- Secondary Outcome Measures
Name Time Method rodynamic parameters (Detrusor leak point pressure, Detrusor sphincter dyssynergia, Incontinence abdominal leak point pressure, Post-void residual volume etc.). <br/ ><br>Electrophysiological parameters (Resting Motor Threshold, Active Motor Threshold, Motor Evoked Potential). <br/ ><br>Functional parameters (Walking index for SCI II, Spinal Cord Independence Measure III). <br/ ><br>Neurological parameters (ASIA impairment scale, Modified Ashworth Scale). <br/ ><br>Psycho-social parameters (Beck Depression Inventory, State Trait Anxiety Inventory II). <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: Baseline and 4 weeks after completion of the intervention.