Accelerated Transcranial Magnetic Stimulation (aTBS) to Treat Depression

NCT ID: NCT03941106

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2023-02-28

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Left aTMS

Group Type: EXPERIMENTAL

Accelerated repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

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

Right aTMS

Group Type: EXPERIMENTAL

Accelerated repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Mental Health, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Mental Health

Singapore, , Singapore

Institute of Mental Health

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: BACKGROUND

PMID: 26909825 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33952345 (View on PubMed)

Other Identifiers

CNIG18may-0001

Identifier Type: -

Identifier Source: org_study_id