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出境医 / 临床实验 / Accelerated Transcranial Magnetic Stimulation (aTBS) to Treat Depression

Accelerated Transcranial Magnetic Stimulation (aTBS) to Treat Depression

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Depression Device: Accelerated repetitive transcranial magnetic stimulation Not Applicable

Detailed 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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Intermittent Accelerated Burst Transcranial Magnetic Stimulation (aTBS) to Treat Depression: a Randomized, Single-blind, Delayed-start Trial
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : May 1, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Left aTMS 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
Experimental: Right aTMS 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
Outcome Measures
Primary Outcome Measures :
  1. Remission as assessed by The Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 3 weeks ]
    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.


Secondary Outcome Measures :
  1. Remission as assessed by The Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 6 weeks ]
    A MADRS score of 10 or less.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Contacts
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Contact: Phern-Chern Tor, MBBS 65-63892000 phern_chern_tor@imh.com.sg

Locations
Layout table for location information
Singapore
Institute of Mental Health Recruiting
Singapore, Singapore
Contact: Phern-Chern Tor, MBBS         
Sponsors and Collaborators
Institute of Mental Health, Singapore
Tracking Information
First Submitted Date  ICMJE April 7, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date May 27, 2020
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2019) 		Remission as assessed by The Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 3 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2019) 		Remission as assessed by The Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 6 weeks ]
A MADRS score of 10 or less.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Accelerated Transcranial Magnetic Stimulation (aTBS) to Treat Depression
Official Title  ICMJE A Pilot Study of Intermittent Accelerated Burst Transcranial Magnetic Stimulation (aTBS) to Treat Depression: a Randomized, Single-blind, Delayed-start Trial
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Left aTMS
    Intervention: Device: Accelerated repetitive transcranial magnetic stimulation
  • Experimental: Right aTMS
    Intervention: Device: Accelerated repetitive transcranial magnetic stimulation
Publications *
  • Tor PC, Gálvez 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.
  • Tan XW, Abdin E, Tor PC. Accelerated transcranial magnetic stimulation (aTMS) to treat depression with treatment switching: study protocol of a pilot, randomized, delayed-start trial. Pilot Feasibility Stud. 2021 May 5;7(1):104. doi: 10.1186/s40814-021-00845-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Phern-Chern Tor, MBBS 65-63892000 phern_chern_tor@imh.com.sg
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03941106
Other Study ID Numbers  ICMJE CNIG18may-0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institute of Mental Health, Singapore
Study Sponsor  ICMJE Institute of Mental Health, Singapore
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institute of Mental Health, Singapore
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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