Effect of Early Coma Arousal Therapy on Conscious Level Recovery and Cognition in Traumatic Brain Injury

NCT05521815 | Completed DMC

• 1 other identifier: 54531
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

PURPOSE: The aim of this study is to investigate the effect of early coma arousal therapy on conscious level and cognitive function in sever traumatic brain injury patients. BACKGROUND: Traumatic brain injury (TBI) could be simply defined as an alteration in brain function due to external forces and is considered as one of the leading cause of death and disability worldwide, especially among young adults and the elderly. Current estimates imply that annual incidence of TBI is 50-60 million worldwide, and specifically for Europe and USA, 0.5% of Europeans and 1.1% of Americans are experiencing a TBI each year. The original scale has since been revised and is known as the Rancho Los Amigos Revised Scale (RLAS-R). One of the limitations of the original eight level scale was that it did not accurately reflect the individuals with higher levels of recovery. Two more levels were added to the initial eight level Ranchos Scale to create a more comprehensive ten level scale named the Rancho Los Amigos Revised Scale (RLAS-R).

Conditions

Traumatic Brain Injury With Loss of Consciousness

Outcome Measures

Primary Outcomes (2)

• conscious level

  is defined as the state of awareness of the self and environment with appropriate arousal or wakefulness. conscious level will be measured using glascow coma scale (GCS), which is a scale used to objectively describe the extent of impaired consciousness in all types of acute medical and trauma patients. The highest possible GCS score is 15, and the lowest is 3. A score of 15 means you're fully awake, responsive and have no problems with thinking ability or memory. Generally, having a score of 8 or fewer means you're in a coma. The lower the score, the deeper the coma is.

  One and half year

• Cognition

  'cognition' refers to all the processes by which the sensory input is transformed, reduced, elaborated, stored, recovered, and used. It is concerned with these processes even when they operate in the absence of relevant stimulation, as in images and hallucinations. cognition will be measured using Rancho Los Amigos Revised Scale (RLAS-R), its a scale used by both medical and rehabilitation providers to measure and track cognitive recovery after traumatic brain injury. It is a 10-point scale where Level I indicates No response/total assistance and Level X indicates Purposeful, appropriate/ modified independent.

  One and half year

Study Arms (2)

Study group

ACTIVE COMPARATOR

The group that are going to receive the coma arousal therapy program

Other: Coma arousal therapy

Control group

PLACEBO COMPARATOR

This group will receive only traditional treatment program

Other: Selected physiotherapy program

Interventions

Coma arousal therapy OTHER

early coma arousal therapy program in addition to selected physical therapy program (positioning, breathing exercise, passive movement of the four limbs).

Study group

Selected physiotherapy program OTHER

selected physiotherapy program only (positioning, breathing exercise, passive movement of the four limbs).

Control group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders.
• Traumatic brain injury with GCS score 3-12.
• Age range from 20-50 years old.
• Must be medically stable post trauma 29

You may not qualify if:

• Patient with other neurological deficits or orthopedic abnormalities that causing disability.
• Patients with pre injury psychiatric disorders.
• Patients with pre injury cognitive disorders.
• Patients who performed surgery post traumatic brain injury.
• Patients not taking the same medications.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr el Aini hospital

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physiotherapist

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 30, 2022
• Study Start: August 23, 2022
• Primary Completion: October 30, 2023
• Study Completion: November 30, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

EG (1)