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A Study of Two Different Treatments for Patients with Reduced Consciousness after Brain Injury

Effect of Early Verticalization Versus Vagus Nerve Stimulation in Patients with Disorders of Consciousness: A Randomized Clinical Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103916
Enrollment
26
Registered
2026-02-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: G939- Disorder of brain, unspecified

Interventions

Intervention1: Early Verticalization: Prior to verticalization, airway patency will be ensured, intravenous infusions will be temporarily suspended, ventilator connections will be checked, and externa

Sponsors

KAHER Institution of Physiotherapy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Informed consent given by the substitute decision maker and medical consultatnt Age above 18 years of all the genders Acquired cerebral damage of knowing etiology Diagnosed with MCS as defined by the CRS-R assessment GCS score of 9-12 Within 4 weeks after brain injury Intact ear skin

Exclusion criteria

Exclusion criteria: Unstable vital signs ( blood pressure, heart rate, respiratory rate or oxygen saturation) Contraindications to verticalization- unstable cervical spine, recent unstable fractures, active deep vein thrombosis in lower limbs, any intravascular devices preventing safe tilt. Significant carotid artery stenosis, significant coronary artery stenosis, hypertrophic cardiomyopathy , severe anemia, known origin of the syncopal event Contraindications to VNS implanted stimulators such as pacemaker or ICD, severe ear or auricular skin lesions, uncontrolled seizures

Design outcomes

Primary

MeasureTime frame
1. Coma Recovery Scale-Revised 2. Glasgow Coma ScaleTimepoint: Baseline and after four weeks

Secondary

MeasureTime frame
Disability rating scale Timepoint: Baseline and after four weeks;Ranchos Los Amigos ScaleTimepoint: Baseline and after four weeks

Countries

India

Contacts

Public ContactSahana Katti

Kle Institute of Physiotherapy, Belagavi

sanjiv3303@rediffmail.com09448745648

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026