The effect of transcranial direct current stimulation and olfactory stimulation in intensive care unit (ICU) patients with disorder of consciousness (DOC)

Evaluating the effect of transcranial direct current stimulation, olfactory stimulation and their combination in intensive care unit (ICU) patients with disorder of consciousness (DOC)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240608062040N1

Enrollment

Registered

2024-06-21

Start date

2024-07-22

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Disorder of consciousness. Altered mental status, unspecified

Interventions

Intervention 1: Intervention group: In the tDCS group, participants received transcranial direct current stimulation in brain regions involved in consciousness, such as the left dorsolateral prefronta

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age above 18 years People with brain damage Non-hemorrhagic cerebrovascular accident (CVA) Glasgow Coma Scale (GCS) greater than 9 No administration of neuromuscular system blockers or sedatives within 24 hours after entering the study Diagnosis of unresponsive wakefulness syndrome (UWS) or minimally conscious state (MCS), based on repeated behavioral assessments using the Coma Recovery Scale-Revised (CRS-R) (ie, at least five assessments per week) Patients without tracheostomy Patients without intracerebral hemorrhage (ICH) Patients without subarachnoid hemorrhage (SAH) Patients without intubation Patients without previous history of neurological or psychiatric disease Patients who did not use neuromuscular blocking drugs or sedative drugs in the 24 hours before the test. Patients with no documented history of previous coma, critical illness, or unstable medical condition Patients with no history of seizures

Exclusion criteria

Exclusion criteria: The patient suffers from a complication that reduces brain function

Design outcomes

Primary

Measure	Time frame
ICU coma scores. Timepoint: Daily during intervention stages. Method of measurement: Glasgow coma scale.;Quantitative electroencephalography(QEEG). Timepoint: At the beginning of the intervention, immediately after the intervention and at the follow-up times (weekly and after 4 weeks of the intervention). Method of measurement: QEEG brain mapping test.	—

Secondary

Measure	Time frame
Safety monitoring of patients. Timepoint: Every week for four weeks after the intervention. Method of measurement: Side effects and potential side effects related to tDCS and olfactory stimulation will be carefully monitored using the Coma Recovery Scale-revised(CRS-R) during the study.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Vafaei

Shahid Beheshti University of Medical Sciences

avafaei.dr@gmail.com+98 21 5541 9005

Outcome results

None listed

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