The survey of transcranial direct current stimulation efficacy on the post-traumatic sleep quality, insomnia severity in the patients with mild traumatic brain injury during sub-acute phase

Phase 1

Recruiting

Conditions: Insomnia in subacute traumatic brain injury.
Intracranial injury

Registration Number: IRCT20130416013027N2

Lead Sponsor: Rasht University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 64

Inclusion Criteria

patients aged 18 to 65 years
Normal and abnormal findings on brain scans within the first 24 hours of hospitalization
all TBI severity
at least 2 weeks to one month after the time of injury onset
The ISI score is over 7 .

Exclusion Criteria

People with a history of primary sleep disorders
taking psychotropic drugs one month before entering the study
having serious neurological and psychiatric disorders
patients with previous traumas
those with tDCS contraception, such as pregnant patients, patients with metal implants or pains, those having a heart pacemaker, taking a psychoactive drug or an effective CNS drug, substance abusers, existence of psychiatric and neurological diseases , a history of seizure, epilepsy, tumor, Neurotrauma, stroke, or neurological diseases, those experiencing skin eczema under the tDCS electrodes
Clinical instability or having behavioral problems that prevent the cooperation of the subject in the intervention
The use of sodium and calcium-dependent calcium channel blockers such as phenytoin, carbamazepine, verapamil, nimesadine, and flonarazine
having a serious complication associated with tDCS
The patient's dissatisfaction with the continuation of the study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The severity of insomnia disorder in patients with traumatic brain injury in subacute phase The score on the Insomnia Disorder Intensity Index (ISI) ranged from 0 to 28. Timepoint: Before starting study and one to three months after starting study. Method of measurement: ISI(Insomnia severty index).;Sleep quality in patients with traumatic brain injury in subacute phase with a total score on the Pittsburgh Sleep Quality Index (PQQI) score between 0 and 21. Timepoint: Before starting study and one to three months after starting study. Method of measurement: PSQI(Pittsburg sleep quality index).

Secondary Outcome Measures