Accelerated Transcranial Magnetic Stimulation (aTBS) to Treat Depression

Depression Clinical Trial

Official title:

A Pilot Study of Intermittent Accelerated Burst Transcranial Magnetic Stimulation (aTBS) to Treat Depression: a Randomized, Single-blind, Delayed-start Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03941106
• Other study ID #: CNIG18may-0001
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: February 28, 2023

Study information

• Verified date: August 2021
• Source: Institute of Mental Health, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aims of this study are to investigate the efficacy of L DLPFC accelerated TMS (aTMS) in patients with depression in Singapore and to assess the whether a 1-week course of treatment is as effective as a 4-week course of non-accelerated treatment and if additional aTMS or different aTMS treatments will be more efficacious in non-responders to initial aTMS treatment.

Description:

Repetitive transcranial magnetic stimulation (TMS) is a technique for stimulating brain activity using transient magnetic field to induce an electrical current in the brain producing firing of focal groups of brain cells. TMS is beginning to emerge in routine clinical practice as a treatment for depression. The predominant hypothesis is that depressed patients benefit from left sided high-frequency TMS (LHF-TMS) over the left dorsolateral prefrontal cortex (DLPFC)(1). A major limitation of rTMS is the large amount of time taken for a standard protocol (38 minutes a day for 20-30 working days). The optimal type and duration of TMS is still uncertain , as is the optimal strategy for continuing or changing type of rTMS if there is poor initial response.(1) One potential strategy to improve the acceptability of rTMS is to compress or accelerate the administration of rTMS (aTMS) by administering multiple sessions of rTMS over a shorter period of time to have equivalent efficacy in shorter period of time. Various studies of aTMS (2-9) have been safely conducted with anywhere from 2 (3) to 10 (2) sessions of rTMS a day for a total of 9 (5) - 20 (4, 7) sessions of TMS over 2 (2) to 9 (8) days. These studies showed that aTMS was safe and efficacious, with no significant side effects reported and a high level of patient acceptability and significant improvements in subjects' depression after the aTMS. However, there is no data on whether subjects who do not response to aTMS will benefit from more of the same TMS or from changing the mode of rTMS. The only study investigating this issue investigated normal rTMS, not aTMS, and did not find a significant difference in response to different forms of rTMS in initial non-responders (10). Our own observations and some preliminary evidence suggest that there may be a delayed response to TMS in some patients (11, 12). Thus, instead of the usual practice of giving 4-6 weeks stimulation (every weekday) and assessing for response at the end of the stimulation period, the same outcome may be achieved by giving a shorter period of stimulation (eg 1 weeks), waiting 2-4 weeks, then assessing response and the need for further TMS treatment. Further, giving more than 1 treatment per day has been shown to be effective (13) and may lead to more efficient treatment, i.e. fewer days to response and less requirement for patient attendance at the treatment centre (2-9). This pilot study will contribute to existing knowledge by being possibly the first group in South East Asia to investigate the immediate and delayed efficacy of aTMS in the local population (i.e. in an Asian setting) as well as whether continuing or changing the type of rTMS is more efficacious in subjects who do not respond to initial aTMS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age =21 years.

2. DSM-V diagnosis of current Major Depressive Episode.

3. Montgomery-Asberg Depression Rating Scale score of 20 or more.

4. Able to give informed consent.

Exclusion Criteria:

1. DSM-V psychotic disorder.

2. Drug or alcohol abuse or dependence (preceding 3 months).

3. Inadequate response to ECT (current episode of depression).

4. Rapid clinical response required, e.g. high suicide risk.

5. Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.

6. Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device.

7. Pregnancy.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Accelerated repetitive transcranial magnetic stimulation
Subjects will be given accelerated left sided rTMS and randomized to more of the same accelerated rTMS if not meeting remission criteria for depression or a different type of rTMS on the right side

Locations

Country	Name	City	State
Singapore	Institute of Mental Health	Singapore
Singapore	Institute of Mental Health	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Mental Health, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

Tor PC, Galvez V, Goldstein J, George D, Loo CK. Pilot Study of Accelerated Low-Frequency Right-Sided Transcranial Magnetic Stimulation for Treatment-Resistant Depression. J ECT. 2016 Sep;32(3):180-2. doi: 10.1097/YCT.0000000000000306. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission as assessed by The Montgomery-Åsberg Depression Rating Scale (MADRS)	The MADRS is a 0-60 point scale to measure depression severity with a higher number indicating more severe depression. Remission from depression is defined as 10 or less. Moderate to severe depression is defined as 20 or more.	3 weeks
Secondary	Remission as assessed by The Montgomery-Åsberg Depression Rating Scale (MADRS)	A MADRS score of 10 or less.	6 weeks