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

Not yet recruiting
Conditions
Disease of spinal cord, unspecified, (2) ICD-10 Condition: 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

Spinal cord injury is a serious condition that produce significant impairment in motor, sensory and autonomic functions. To manage spinal cord injury conventional treatment have been employed such as: pharmacological, surgical and rehabilitation etc., few novel treatment strategies are under investigation to expect a better recovery. Intermittent theta burst stimulation is one of such non-invasive neuromodulation technique. Impaired gait and neurogenic bladder are major consequences of spinal cord injury with fatal outcome but less commonly addressed in previous literature.  We hypothesize that  cortical application of intermittent theta burst stimulation will improve gait pathomechanics and neurogenic lower urinary tract dysfunction in incomplete spinal cord injury patients.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
60
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.
  • 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
NameTimeMethod
Spatio- Temporal parameters of Gait (Walking speed, Stride length, Cadence etc)Baseline and 4 weeks after completion of the intervention
Secondary Outcome Measures
NameTimeMethod
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).

Trial Locations

Locations (1)

AIl India Institute of Medical Sciences

🇮🇳

Delhi, DELHI, India

AIl India Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
Rohit Banerjee
Principal investigator
6290276465
rohitphysio96@gmail.com

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