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

Primary Purpose

Effect of Early Coma Arousal Therapy on Conscious Level and Cognitive Function in Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Coma arousal therapy
Selected physiotherapy program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Effect of Early Coma Arousal Therapy on Conscious Level and Cognitive Function in Traumatic Brain Injury

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Kasr el Aini hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Study group

Control group

Arm Description

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

This group will receive only traditional treatment program

Outcomes

Primary Outcome Measures

To see the significance of applying early arousal coma therapy on comatose patients.
Glasgow coma scale assessment through out the one and half year for the patients, its a scale used to determine the conscious level in patients post traumatic brain injury where lower score present that the patient conscious lev is deteriorated and higher scores mean that the patient conscious level is good
To see the significance of applying early arousal coma therapy on comatose patients.
Rancho los amigos scale, to assess the cognitive state of patients post traumatic brain injury, it consists of 10 levels, and lower level represent bad cognitive state while higher level represent good cognitive state

Secondary Outcome Measures

Full Information

First Posted
August 23, 2022
Last Updated
August 29, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05521815
Brief Title
Effect of Early Coma Arousal Therapy on Conscious Level Recovery and Cognition in Traumatic Brain Injury
Official Title
Effect of Early Coma Arousal Therapy on Conscious Level Recovery and Cognition in Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2022 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Early Coma Arousal Therapy on Conscious Level and Cognitive Function in Traumatic Brain Injury

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Active Comparator
Arm Description
The group that are going to receive the coma arousal therapy program
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
This group will receive only traditional treatment program
Intervention Type
Other
Intervention Name(s)
Coma arousal therapy
Intervention Description
early coma arousal therapy program in addition to selected physical therapy program (positioning, breathing exercise, passive movement of the four limbs).
Intervention Type
Other
Intervention Name(s)
Selected physiotherapy program
Intervention Description
selected physiotherapy program only (positioning, breathing exercise, passive movement of the four limbs).
Primary Outcome Measure Information:
Title
To see the significance of applying early arousal coma therapy on comatose patients.
Description
Glasgow coma scale assessment through out the one and half year for the patients, its a scale used to determine the conscious level in patients post traumatic brain injury where lower score present that the patient conscious lev is deteriorated and higher scores mean that the patient conscious level is good
Time Frame
One and half year
Title
To see the significance of applying early arousal coma therapy on comatose patients.
Description
Rancho los amigos scale, to assess the cognitive state of patients post traumatic brain injury, it consists of 10 levels, and lower level represent bad cognitive state while higher level represent good cognitive state
Time Frame
One and half year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Both genders. Traumatic brain injury with GCS score 3-12. Age range from 20-50 years old. Must be medically stable post trauma 29 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa Samir, Master's
Phone
+201016363593
Email
Dr_mustafa1990@hotmail.com
Facility Information:
Facility Name
Kasr el Aini hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed

12. IPD Sharing Statement

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

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