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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130416013027N2

Enrollment

Registered

2019-12-23

Start date

2019-08-26

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

Insomnia in subacute traumatic brain injury. Intracranial injury

Interventions

Intervention 1: Intervention group:32 patients. The group receiving the actual tDCS. Anodal tDCS is performed on the right DLPFC and cathodal on the left shoulder with a 1.5 mA excitation intensity an

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZohair Reihanian

Rasht University of Medical Sciences

zoheir.reihanian@gmail.com+98 13 3336 8773

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026