Assessing the level of consciousness. Concussion without loss of consciousness
Conditions
Interventions
Intervention 1: Intervention group: Atomoxetine, manufactured in Iran by Tehran Darou Pharmaceutical Company, will be given 20 mg twice daily (7 am and 12 pm) during the first week (1st week BD mg 20)
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age 18 to 65 years Documented history of moderate to severe traumatic brain injury (TBI) (GCS = 12 or evidence of intracranial injury on CT or MRI imaging) Recovery time from injury: 1 to 12 months Persistent functional disability (DRS = 6 from baseline) Ability to give informed consent Medical stability in patients undergoing treatment and evaluation outside the hospital
Exclusion criteria
Exclusion criteria: History of previous neurological conditions unrelated to TBI (such as epilepsy, stroke, dementia) Recent or current (within the past three months) substance abuse according to DSM-5 criteria Use of contraindicated medications such as monoamine oxidase inhibitors (MAOIs), stimulants or norepinephrine reuptake inhibitors (e.g., methylphenidate, bupropion), and use of medications that interact with atomoxetine or amantadine Having severe neuropsychiatric disorders (such as severe psychosis, severe major depression, or suicidal thoughts requiring immediate treatment) Known prior allergy to atomoxetine or amantadine Having uncontrolled cardiovascular disease (such as significant arrhythmia, recent MI, or severe hypertension) Having severe liver or kidney disorders Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional status. Timepoint: At weeks 0, 4, 8, and 12. Method of measurement: Disability Rating Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive function assessment. Timepoint: At weeks 0, 4, 8, and 12. Method of measurement: Using the Stroop Color-Word Test and MoCA.;Behavioral assessments. Timepoint: Every two weeks. Method of measurement: Using ASRS and WCFS.;Safety assessments including vital signs. Timepoint: In week 2. Method of measurement: ECG. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSajad Najafi
Mazandaran University of Medical Sciences
Outcome results
None listed