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A clinical trail to assess and compare the role of continuous theta burst stimulation (cTBS) over two areas of brain namely,right dorsolateral prefrontal cortex v/s supplementary motor area in patients with obsessive compulsive disorder adjunctive to pharmacological treatment.

Comparative efficacy of adjunctive continuous theta burst stimulation of right dorsolateral prefrontal cortex v/s supplementary motor area in obsessive compulsive disorder: A randomized double-blind sham controlled trial - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/068105
Enrollment
90
Registered
2024-05-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: G- Mental Health

Interventions

Intervention1: Continuous theta-burst stimulation over supplementary motor area: Continuous theta bust stimulation (cTBS)over bilateral supplementary motor area will be given in patients with Obsessiv

Sponsors

Dr Arpita K S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age between 18 to 60 years 2.Subjects who give consent for participation 3.Subjects meeting ICD 10 ( DCR) criteria for obsessive compulsive disorder and have more thn 16 score on YBOCS

Exclusion criteria

Exclusion criteria: 2. Current ICD 10 ( DCR) diagnosis of Severe depressive disorder, suicidal ideations , schizophrenia or any other psychotic disorder, or any other severe comorbid psychiatric illness, or substance use disorder. 2. Standard rTMS contraindications like history of epilepsy, metal implants near the head in any part of the body, history of neurosurgical operations , pacemaker implant, evaluated using TMS adult safety screen (TASS) questionnaire.3. Concurrent use of medications or drugs that are known to reduce the seizure threshold. 4.Acute or chronic debilitating physical illness.5. Pregnancy. 6.Subjects with intellectual disabilities.

Design outcomes

Primary

MeasureTime frame
It is expected that participants in both the active right DLPFC cTBS and SMA cTBS groups will show a significant reduction in overall symptom severity, functional impairment, and improvement in quality of life in comparison to sham controls, but, there will be no significant difference between the active stimulation groups i.e. right DLPFC cTBS and SMA cTBS in terms of symptom reduction, functional improvement, and quality of life measures scored by Yale Brown obsessive compulsive scale (YBOCS) ) and Clinical global impression global improvement/change scale.Timepoint: Outcomes will be assessed at 0,7,14,28, and 60 days from the start of intervention, by another independent psychiatrist who will not be involved in administering cTBS and will unaware of the allocation of patients in different groups .

Secondary

MeasureTime frame
Depression and Anxiety will be assessed by Hamilton depression rating scale (HAMD17), Hamilton anxiety rating scale ( HAM A) ,Timepoint: Outcomes assessment on 0,7,14,28 and 60 days

Countries

India

Contacts

Public ContactDr Arpita K S

Institute of Psychiatry, Kolkata

sujitsarkhel@gmail.com9836074700

Outcome results

None listed

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