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Theta Burst Stimulation (TBS) in Treatment Resistant Obsessive Compulsive Disorder.

Theta Burst Stimulation (TBS) in Treatment Resistant Obsessive Compulsive Disorder.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000666426
Acronym
TBS for OCD
Enrollment
11
Registered
2016-05-23
Start date
2017-09-01
Completion date
2018-12-20
Last updated
2022-05-30

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

Conditions

None listed

Brief summary

This study is assessing the efficacy of Theta Burst Stimulation (TBS), a form of Transcranial Magnetic Stimulation (TMS), in treating Obsessive Compulsive Disorder (OCD). It is a randomised control trial where participants will receive bilateral TBS to one of two different brain cortical regions. Each treatment course will involve TBS twice daily for 2 weeks (10 treatment days). Each treatment session will involve the application of 2 TBS trains, 15 minutes apart (a total of 4 trains per day and 40 trains per treatment course). Patients who do not respond to treatment will be crossed over and provided the alternate treatment. During treatment patients will be reclined in a comfortable chair and will be alert and awake. The sensation associated with treatment is usually well tolerated with most people describing it as a tapping sensation.

Interventions

It is a parallel group clinical trial where participants will receive bilateral TBS to either the orbital frontal cortex (OFC) or the supplementary motor area (SMA). Each treatment course will involve TBS treatment twice daily for 2 weeks (10 treatment days). Each treatment session will involve the application of 2 TBS trains, 15 minutes apart (a total of 4 trains per day and 40 trains per treatment course). Patients who do not respond to treatment will be crossed over and provided the alternate

It is a parallel group clinical trial where participants will receive bilateral TBS to either the orbital frontal cortex (OFC) or the supplementary motor area (SMA). Each treatment course will involve TBS treatment twice daily for 2 weeks (10 treatment days). Each treatment session will involve the application of 2 TBS trains, 15 minutes apart (a total of 4 trains per day and 40 trains per treatment course). Patients who do not respond to treatment will be crossed over and provided the alternate treatment one month after their initial treatment had ended. During treatment patients will be reclined in a comfortable chair and will be alert and awake. The sensation associated with treatment is usually well tolerated with most people describing it as a tapping sensation. TBS will be applied in a single 40 - second train per application. Three pulses per burst will be applied at 50 Hz and the bursts repeated at 5 Hz. The treatment intensity for both rTMS and TBS will be 120% of resting motor threshold which is measured by administering single pulse TMS to the muscle controlling area of the brain.

Sponsors

Epworth HealthCare
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

- Have DSM-5 diagnosis of OCD - Are treatment resistant - Have had no changes in medications in 6 weeks prior to screening

Exclusion criteria

- An unstable medical condition, neurological disorder, history of seizure disorder or currently pregnant or lactating -A current diagnosis of substance abuse or dependence, a personality disorder or other psychiatric disorder, except depression or another anxiety disorder - Any contraindication to TMS

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026