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The effect of tACS and tNRS methods in mTBi patients

Investigation and comparison of the effects of transcranial random noise stimulation (tRNS) and transcranial alternating current stimulation (tACS) on attention and working memory in patients with mild traumatic brain injury (mTBI).

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230405057822N2
Enrollment
60
Registered
2025-06-28
Start date
2025-07-23
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Attention and working memory impairment in patients with mild traumatic brain injury (mTBI). Personality change due to known physiological condition

Interventions

Intervention 1: The device used in this study is the registered and proprietary "Neurotis 8" system, powered by a 9-volt alkaline battery. The maximum electrical current intensity is 2 mA, which is de

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age group between 18 and 65 years old mTBI as diagnosed by an emergency medicine specialist (GCS 13-15, coma duration 30 minutes or less, and post-PTA amnesia less than 24 hours) Level of consciousness between (13-15) on the Glasgow Coma Scale (GCS); Head trauma with loss of consciousness (LOC) or alteration of consciousness/mental state (AOC) (such as impaired cognition and attention, impaired consciousness) within 24 hours of the incident Local or diffuse damage to brain tissue caused by an external mechanical force. Duration of post-traumatic amnesia 0 to 1 day after the incident, ability to participate in tRNS and tACS treatment protocol Ability to collaborate in qEEG recording and cognitive assessment testing; Also, filling out the informed consent form.

Exclusion criteria

Exclusion criteria: History of using tRNS and tACS to treat any disorder Presence of any neurological disease prior to TBI or brain injury of non-traumatic origin (such as brain tumors, multiple sclerosis, stroke, aneurysm, and other cerebrovascular events) Presence of intracranial metal implants (such as pacemakers and electrodes) Co-morbidity with any known major physical or psychiatric disorder Significant cerebral hemorrhage: Patients with epidural or subdural hematoma, or any other type of cerebral hemorrhage requiring surgical intervention. Advanced or uncontrolled cerebral hemorrhage: Patients with extensive cerebral hemorrhages and conditions that required immediate interventions to manage their condition were excluded from the study. Bleeding, history of seizures or epilepsy; use of carbamazepine and flunarizine due to interference with the effectiveness of tRNS and any drugs affecting the nervous system patients who do not consent to participate in the study for any reason. Among the ethical considerations that will be observed in this study are the ethical codes 4-8 and 5-8 of the Ethical Code of the Psychology and Counseling System Organization of the Islamic Republic of Iran, which include completely voluntary participation in the research and the absence of any negative consequences if individuals are unwilling to continue cooperation.

Design outcomes

Primary

MeasureTime frame
Attention. Timepoint: Before and after the intervention and three months after the end of the intervention. Method of measurement: Rehacom and qeeg test.;Working memory. Timepoint: Before and after the intervention and three months after the end of the intervention. Method of measurement: Rehacom and qeeg test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Hamid Mirhosseini

Yazd University of Medical Sciences

mirhosseini@ssu.ac.ir+98 35 3623 8626

Outcome results

None listed

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