Accelerated Rotational Field Deep TMS for Treating OCD

ConditionObsessive-Compulsive Disorder

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorBen-Gurion University of the Negev

About this trial

A Prospective Double Blind Randomized Controlled Trial to Evaluate the Efficacy and Durability of the BrainsWay Rotational Field Deep Transcranial Magnetic Stimulation (Deep TMS) in Obsessive-Compulsive Subjects

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Outpatients

Diagnosed as suffering from OCD according to the DSM-V.

Subjects with a YBOCS score of >20.

If on SRI, patient must be maintained on current dosages (with or without additional antidepressant or psychotropic augmentation for treatment of OCD), at a stable therapeutic dosage for at least 2 months prior to study entry and for the duration of the trial.

Disqualifiers

Subjects diagnosed as suffering from any other Axis I diagnosis as the primary diagnosis.

Comorbid, secondary psychiatric diagnoses are unstable and are likely to require changes in therapeutic regimens even if OCD improves.

Present suicidal risk as assessed by the investigator using the Columbia Suicide Severity Rating Scale, brief mental status exam and psychiatric interview or a history of attempted suicide in the past year.

History of epilepsy or seizure (EXCEPT those therapeutically induced by ECT and febrile seizures in infancy).

Trial design

Design model

Parallel

Treatments tested in this trial

BrainsWay Deep TMS HAC/H7-Coil
Device
Rotational field TMS (rfTMS) is a novel technology where two orthogonal coils are operated with a 90 phase shift between them. The combined electric field vector of rfTMS from both coils rotates up to a complete cycle during the TMS pulse. This method overcomes the inherent limitation of conventional unidirectional TMS by influencing neurons in various orientations (Roth et al., 2020b). This unique advance bears enormous potential for therapeutic applications in various neuropsychiatric disorders. The coil Array includes the H7 coil as the lower coil, and an upper coil perpendicular to it. Hence, the HAC/H7 coil Array induces similar electric field distribution and affects the same brain structures as the H7 coil, but stimulates neurons in various orientations within these regions.
BrainsWay Deep TMS Sham Coil
Device
Participants assigned to this intervention will receive sham stimulation using a BrainsWay Deep TMS sham coil that mimics the sensation and acoustic properties of active stimulation but does not deliver effective magnetic pulses to the brain. This condition is used as a placebo control to blind participants and investigators.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Active TMSExperimental treatment 1 intervention

Group B: Sham TMSSham comparator 1 intervention

Trial outcomes

Primary outcomes

Yale Brown Obsessive Compulsive Scale (YBOCS)

Change in YBOCS scores from baseline to the end of six weeks between the active Deep TMS and Sham treatment groups. Scores on the YBOCS range from 0 (no Symptoms) to 40 (Extreme Symptoms).

Time frame

6 weeks

Secondary outcomes

Yale Brown Obsessive Compulsive Scale (YBOCS)

Change in YBOCS scores from baseline to the end of thirteen weeks between the active Deep TMS and Sham treatment groups.

Time frame

13 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ben-Gurion University of the Negev

Lead sponsor

Brainsway

Collaborator

Source ClinicalTrials.gov

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