Effectiveness Of Magnetic Stimulation Of Brain In Treatment Of Insomnia Disorder.

“Efficacy And Safety Of Continuous Theta Burst Stimulation Over Dorsolateral Prefrontal Cortex In Insomnia Disorder: A Randomized Sham Controlled Trial ?

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075898

Enrollment

Registered

2024-10-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: G470- Insomnia

Interventions

Intervention1: continous theta burst magnetic stimulation: cTBS will be delivered in 3 sessions per day in right DLPFC area more than half an hour apart for 7 days. Intervention2: continous theta burs

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patient with a diagnosis of INSOMNIA DISORDER based on the diagnostic criteria of diagnostic and statistical manual of mental disorder, fifth edition (DSM 5) 2)Screening cut-off less than 16 as per Sleep condition indicator (SCI) 3)Patients aged above 18 years. 4)Patient willing to participate in the study and give written consent for the same.

Exclusion criteria

Exclusion criteria: 1.Patient is uncooperative for the procedure. 2.Patients with neurological disorders with history of epilepsy, organic brain damage or any neurological procedures 3.Patients with implanted metallic devices 4.Patients receiving ECT in past 6 months. 5.Patients with significant unstable medical conditions like uncontrolled hypertension, complicated diabetes mellitus, organic failures, etc. 6.Pregnant and lactating female. 7.Patient with mental disorder except comorbid major depressive disorder and anxiety disorders as per DSM-5 (APA, 2013) 8.Any co-morbid current substance use disorders except nicotine and caffeine as per DSM-5 (APA, 2013)

Design outcomes

Primary

Measure	Time frame
To assess efficacy and safety of continuous theta burst stimulation over dorsolateral prefrontal cortex in insomnia disorder: a Randomized sham controlled trialTimepoint: PSQI, ISI, FOSQ-10 and WHOQOL-BREF scores will be assessed at baseline, 10th day and 25th day.	—

Secondary

Measure	Time frame
To compare the pre-post changes in subjective sleep parameters, quality of life and safety in patients suffering from insomnia disorder following active continuous theta burst stimulation and sham continuous theta burst stimulation.Timepoint: PSQI, ISI, FOSQ-10 and WHOQOL-BREF scores will be assessed at baseline, 10th day and 25th day.	—

Countries

India

Contacts

Public ContactDr Neetu Garg

Sri Guru Ram Rai Institute Of Medical and Health Sciences

shobit.garg@gmail.com8958534261

Outcome results

None listed

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