DepressionNCT03941106
Accelerated Transcranial Magnetic Stimulation (aTBS) to Treat Depression
A study testing Accelerated repetitive transcranial magnetic stimulation in people with Depression, run by Institute of Mental Health, Singapore at 2 sites in Singapore.
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… Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Depression
- What is being tested?
- Accelerated repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesSingapore
- Study dates
- 1 Jul 2019to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥21 years.
- DSM-V diagnosis of current Major Depressive Episode.
- Montgomery-Asberg Depression Rating Scale score of 20 or more.
- Able to give informed consent.
Who cannot join
- DSM-V psychotic disorder.
- Drug or alcohol abuse or dependence (preceding 3 months).
- Inadequate response to ECT (current episode of depression).
- Rapid clinical response required, e.g. high suicide risk.
- Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.
- Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device.
- Pregnancy.
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Institute of Mental Health
Singapore, 539747
Institute of Mental Health
Singapore
About this study
Official title: A Pilot Study of Intermittent Accelerated Burst Transcranial Magnetic Stimulation (aTBS) to Treat Depression: a Randomized, Single-blind, Delayed-start Trial
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Accelerated repetitive transcranial magnetic stimulation
- Keywords
- rTMS, depression, accelerated
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated repetitive transcranial magnetic stimulationDevice
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 group | Role | What they receive |
|---|---|---|
| Left aTMS | Experimental | Not described Receives: Device: Accelerated repetitive transcranial magnetic stimulation |
| Right aTMS | Experimental | Not described Receives: Device: Accelerated repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (1)
Remission as assessed by The Montgomery-Åsberg Depression Rating Scale (MADRS)
A MADRS score of 10 or less.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Jul 2019
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Mental Health, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941106
- Sponsor's protocol ID
- CNIG18may-0001
- Status last verified
- Aug 2021
- First submitted
- 7 Apr 2019
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26909825Tan 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.
PubMed 33952345
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Intermittent Accelerated Burst Transcranial Magnetic Stimulation (aTBS) to Treat Depression: a Randomized, Single-blind, Delayed-start Trial
- ClinicalTrials.gov ID
- NCT03941106
- Acronym / sponsor ID
- CNIG18may-0001
- Conditions
- Depression
- Keywords
- rTMS, depression, accelerated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Institute of Mental Health, SingaporeUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left aTMS | Experimental | Device: Accelerated repetitive transcranial magnetic stimulation |
| Right aTMS | Experimental | Device: Accelerated repetitive transcranial magnetic stimulation |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥21 years.
- DSM-V diagnosis of current Major Depressive Episode.
- Montgomery-Asberg Depression Rating Scale score of 20 or more.
- Able to give informed consent.
Key exclusion criteria (7 listed)
- DSM-V psychotic disorder.
- Drug or alcohol abuse or dependence (preceding 3 months).
- Inadequate response to ECT (current episode of depression).
- Rapid clinical response required, e.g. high suicide risk.
- Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated repetitive transcranial magnetic stimulationSubjects 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 | Device | Left aTMS, Right aTMS |
Primary outcome
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.
1 secondary outcome
Remission as assessed by The Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 26909825Tor 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.
- Derived from this study: PubMed 33952345Tan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated repetitive transcranial magnetic stimulation in people with Depression, run by Institute of Mental Health, Singapore at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission as assessed by The Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03941106, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.