Accelerated Intermittent Theta Burst Stimulation for Depressed Patients During the Covid-19 Pandemic

Treatment Resistant Depression Clinical Trial

Official title:

Accelerated Intermittent Theta Burst Stimulation for Depressed Patients During the Covid-19 Pandemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04935489
• Other study ID #: 21-008-B
• Status: Completed
• Phase: N/A
• Start date: January 12, 2022
• Est. completion date: January 15, 2023

Study information

• Verified date: March 2023
• Source: Ontario Shores Centre for Mental Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Repetitive Transcranial Magnetic Stimulation (rTMS) using intermittent theta burst stimulation (iTBS) has been found to be a non inferior protocol to standard rTMS for the treatment of major depressive disorder. An accelerated course is of particular interest given the safety profile of the procedure and the potential to treat people more quickly making the treatment more accessible. This study aims to assess the feasibility and clinical outcomes of a high dose iTBS protocol in patients with depression in the context of unipolar or bipolar II disorder who are waiting for Electroconvulsive therapy (ECT) or rTMS due to degree of treatment resistance or severity of symptoms. This is a prospective, open-label, interventional pilot study wherein patients who have been diagnosed with major depressive disorder and referred to brain stimulation clinic, will be recruited for the treatment. Patients will be administered eight questionnaires before and after the treatment to assess the change in clinical outcomes.

Description:

Participants will receive same stimulation protocol, however they will be given 6 times per day instead of once per day. Each Treatment will consist of a single iTBS treatment delivering 600 puses of iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duy cycle of 2 seconds on, 8 seconds off, over 60 cycles and it takes about 3 minutes at a target of 90 to 120% of the subject's resting motor threshold. Treatment will be given through the device that is usually used, which is Magpro by Magventure, B70 Fluid-Cooled Coil .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older
• Unipolar Depression or Bipolar II depression based on the MINI - no psychotic features
• Pass the TMS safety screen on the brain stimulation consultation template Voluntary and Competent to consent to treatment

Exclusion Criteria:

• Have a MINI confirmed diagnosis of a substance use disorder within the last month
• Have a concomitant major unstable medical illness, cardiac pacemaker or implanted mediation pump
• Have a lifetime MINI diagnosis of bipolar I, or schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder.
• Have any significant neurological disorder or insult including but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT, or a febrile seizure of infancy or single seizure related to a known drug related event, cerebral aneurysm, or significant head trauma with loss of consciousness for greater than 5 minutes
• Have an intracranial implant (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head (excluding the mouth) that cannot be safely removed.
• Currently taking more than lorazepam 2mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy.

Related Conditions & MeSH terms

• COVID-19
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

Device:
• Intermittent Theta Burst Stimulation (form of repetitive transcranial magnetic stimulation) given in an accelerated form
The intervention is used regularly for patients with treatment resistant depression, however, in this trial it will be given multiple times per day and over less days than the usual protocol

Locations

Country	Name	City	State
Canada	Robyn	Whitby	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ontario Shores Centre for Mental Health Sciences

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse effects of the treatment	Looking at occurrence of adverse effects - screened during/after each treatment	during and after each rTMS treatment during acute treatment and up to a week after treatment
Primary	Remission of depressive symptoms using the Hamilton Depression Rating Scale (HAM - D or HDRS) - 17 version	Severity of depressive symptoms being measured pre and post treatment - remission is less than 8 (low score is less depression, higher score - more depressive symptoms, range is 0 to 53)	at screening (within a week of starting treatment) to a week post treatment
Secondary	Response to treatment with reduction of 50% in depressive symptoms on HAM-D - 17 and PHQ - 9 (patient health questionnaire)	Change in severity of depressive symptoms (same as primary outcome description)	at screening (within a week of starting treatment) to a week post treatment
Secondary	Response of anxiety symptoms - reduction by 50% - Generalized Anxiety disorder scale (GAD-&)	Change in severity of anxiety symptoms - higher the score, more anxiety symptoms, range 0 to 21	at screening (within a week of starting treatment) to a week post treatment
Secondary	Change in World Health Organization Disability assessment scale (WHODAS)	severity of disability ( 40 to 180 - higher score = more disabled)	at screening (within a week of starting treatment) to a week post treatment
Secondary	Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (QUAL-ES-Q)	Change in rated quality of life, score range from 14 to 70 ( higher score = better quality of life)	at screening (within a week of starting treatment) to a week post treatment
Secondary	Improvement overall using the Clinical Global Severity/Impression Scale (CGI-I)	Change in severity of illness (1 - much worse, 7 - most improved)	at screening (within a week of starting treatment) to a week post treatment
Secondary	Patient Health Questionnaire (PHQ-9) - Response to symptoms	reduction in depression score by 50% - higher the score - more depressive symptoms, scored from 0 to 27	at screening (within a week of starting treatment ) to a week post treatment