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Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation

Primary Purpose

Suicidal Ideation, Major Depressive Disorder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MagVenture TMS Therapy System w/Theta Burst Stimulation

Sham MagVenture TMS Therapy System w/Theta Burst Stimulation

About this trial

This is an interventional treatment trial for Suicidal Ideation focused on measuring Adolescent

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inpatients or outpatients
Voluntary clinical patient with the capacity to assent to treatment and a parent or legal guardian with the capacity to consent
Female or male
12-18 years of age
Diagnosed with MDD based on Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) criteria122 with the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid) in subjects 12-17 years of age;118 The Mini-International Neuropsychiatric Interview will be used for subjects who are 18 years of age117
In a current episode of MDD with duration of at least 4 weeks but less than 3 years
Depressive symptom severity as demonstrated by CDRS-R total composite score of 40 or greater and a suicidal ideation score of 3 or more on item 13 of the CDRS-R109
Demonstrating that depressive symptom severity as evaluated at the screening visit does not improve between screening and baseline by 25% or more
Eligible for transcranial magnetic stimulation (TMS) based on safety criteria104
On a medically acceptable form of birth control if female
Taking an antidepressant medication if recommended by the referring clinician and agreed upon by parents and patients. Please note that patients are not required to take an antidepressant medication for study participation for practical, ethical, and human subject protection concerns. Medication status and prior treatment resistance will be carefully recorded with the Antidepressant Treatment History Form113 criteria for relevant statistical considerations.

Exclusion Criteria:

Diagnosis of a psychotic disorder, bipolar disorder, anorexia nervosa, bulimia nervosa, substance use disorders within the past year (with the exception of caffeine and tobacco).
Intelligent quotient less than 70 (if there is a clinical concern, subjects will be psychometrically assessed with the Slosson Intelligence Test, Revised).123
Positive urine drug screen at baseline
Seizure history
Any family history of epilepsy
History of any treatment with electroconvulsive therapy or TMS
Use of any investigational drug within 4 weeks of baseline
Prior brain surgery
Risk for increased intracranial pressure such as a brain tumor
Head trauma with loss of consciousness
Any true positive findings on the TMS safety screening form
Pregnancy or suspected pregnancy
Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the head-within 30 cm of the treatment coil excluding the mouth that cannot be safely removed (examples include cochlear implants, vagus nerve stimulators, deep brain stimulators, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes).
Implanted medication pumps and cardiac pacemakers
Any unstable medical condition
Inability to adhere to the protocol

Sites / Locations

Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Sequential bilateral accelerated theta burst stimulation

Sham seqential billateral accelerated theta burst stimulation

Arm Description

Three sessions of Sequential bilateral accelerated theta burst stimulation (aTBS) are administered daily for 10 days (5 days per week).

Three sessions of Sequential bilateral sham accelerated theta burst stimulation (aTBS) are administered daily for 10 days (5 days per week).

Outcomes

Primary Outcome Measures

Suicidal Ideation

Suicidal Ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS). This is a validated, clinician-rated tool collected to assess lifetime and ongoing suicidal ideation and behavior. The severity of ideation subscale is a 5-point ordinal scale 1-5 . 1 = Wish to be dead - 5 = Active Suicidal Ideation with Specific Plan and Intent. Assessed at baseline, 10 days and 12 months.

Hospitalizations

The total number of hospitalizations related to suicide idealization

Secondary Outcome Measures

Cortical inhibition

As measured in Changes in test stimulus (TS) motor evoked potential (MEP) amplitude of are expressed as a percentage of the mean unconditioned MEP amplitude. For N100 response data collection, mean single pulse data will be collected for each electrode for the TMS-evoked potential. The N100 peak value is then extracted throughout electrodes from the negative in closest proximity to 100 ms.

Full Information

NCT ID

NCT04502758

First Posted

August 4, 2020

Last Updated

July 10, 2023

Sponsor

Mayo Clinic

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT04502758

Brief Title

Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation

Official Title

A Randomized Controlled Trial of Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation Associated With Major Depressive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 4, 2022 (Actual)

Primary Completion Date

December 2027 (Anticipated)

Study Completion Date

December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to gather information regarding the use of a new type of transcranial magnetic stimulation (TMS) called theta burst stimulation (TBS) for suicidal ideation in adolescents with Major Depressive Disorder (MDD). The investigators hope to learn if this TMS treatment improves suicidal ideation over 10 days and clinical outcomes over 1 year of follow-up.

Detailed Description

The proposed study will examine sequential bilateral accelerated theta burst stimulation (aTBS). Three sessions are administered daily for 10 days (5 days per week). During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The theta burst stimulation (TBS) parameters were adopted from prior work, with 3-pulse 50 Hz bursts given every 200 ms (at 5 Hz) with an intensity of 80% of active motor threshold. The comparison group will receive 3 daily sessions of bilateral sham TBS treatment for 10 days. Subjects in both groups will take part in a daily psychotherapeutic treatment program. The proposed study will examine sequential bilateral accelerated theta burst stimulation (aTBS). Three sessions are administered daily for 10 days (5 days per week). During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The theta burst stimulation (TBS) parameters were adopted from prior work, with 3-pulse 50 Hz bursts given every 200 ms (at 5 Hz) with an intensity of 80% of active motor threshold. The comparison group will receive 3 daily sessions of bilateral sham TBS treatment for 10 days. Subjects in both groups will take part in a daily psychotherapeutic treatment program. The study will enroll outpatient and inpatient adolescents (aged 12-18 years) with Major Depressive Disorder (MDD) of at least moderate severity defined as a Children's Depression Rating Scale Revised (CDRS-R) Score of 40 or greater and suicidal ideation defined as a score of 3 or greater on item 13 (Suicidal Ideation) of the CDRS-R.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Suicidal Ideation, Major Depressive Disorder

Keywords

Adolescent

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized Controlled Trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The use of the MagVenture Cool-B70 A/P coils facilitates blinding of the operator and subjects receiving aTBS or sham treatments. The study team members completing clinical rating scales will also not be allowed in the treatment suite during TBS treatment sessions and will be blinded to treatment assignment. A pre-post treatment expectancy and experience form will ask subjects and parents to make a guess regarding treatment arm (active or sham). Blinded study team members will also be asked to guess treatment assignments for each subject.

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sequential bilateral accelerated theta burst stimulation

Arm Type

Active Comparator

Arm Description

Three sessions of Sequential bilateral accelerated theta burst stimulation (aTBS) are administered daily for 10 days (5 days per week).

Arm Title

Sham seqential billateral accelerated theta burst stimulation

Arm Type

Sham Comparator

Arm Description

Three sessions of Sequential bilateral sham accelerated theta burst stimulation (aTBS) are administered daily for 10 days (5 days per week).

Intervention Type

Device

Intervention Name(s)

MagVenture TMS Therapy System w/Theta Burst Stimulation

Other Intervention Name(s)

The MagVenture TMS Therapy System w/Theta Burst Stimulation

Intervention Description

During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The device consists of a magnetic stimulator, MagPro X100 and a magnetic coil used for MT determination, C-B70 and a treatment coil, the Cool-B70 A/P coil. The A/P version of the coil, contains both an active site (A) and a sham (P) site. The magnetic field properties on the active site are identical to that of the standard Cool-B70 coil, cleared for iTBS treatment.

Intervention Type

Device

Intervention Name(s)

Sham MagVenture TMS Therapy System w/Theta Burst Stimulation

Intervention Description

During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The device consists of a magnetic stimulator, MagPro X100 and a magnetic coil used for MT determination, C-B70 and a treatment coil, the Cool-B70 A/P coil. The A/P version of the coil, contains both an active site (A) and a sham (P) site. The magnetic field on the sham site is significantly reduced, and is less than 5% of that of the active site.

Primary Outcome Measure Information:

Title

Suicidal Ideation

Description

Time Frame

up to 12 months

Title

Hospitalizations

Description

The total number of hospitalizations related to suicide idealization

Time Frame

up to 12 months

Secondary Outcome Measure Information:

Title

Cortical inhibition

Description

Time Frame

baseline, 10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Inpatients or outpatients Voluntary clinical patient with the capacity to assent to treatment and a parent or legal guardian with the capacity to consent Female or male 12-18 years of age Diagnosed with MDD based on Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) criteria122 with the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid) in subjects 12-17 years of age;118 The Mini-International Neuropsychiatric Interview will be used for subjects who are 18 years of age117 In a current episode of MDD with duration of at least 4 weeks but less than 3 years Depressive symptom severity as demonstrated by CDRS-R total composite score of 40 or greater and a suicidal ideation score of 3 or more on item 13 of the CDRS-R109 Demonstrating that depressive symptom severity as evaluated at the screening visit does not improve between screening and baseline by 25% or more Eligible for transcranial magnetic stimulation (TMS) based on safety criteria104 On a medically acceptable form of birth control if female Taking an antidepressant medication if recommended by the referring clinician and agreed upon by parents and patients. Please note that patients are not required to take an antidepressant medication for study participation for practical, ethical, and human subject protection concerns. Medication status and prior treatment resistance will be carefully recorded with the Antidepressant Treatment History Form113 criteria for relevant statistical considerations. Exclusion Criteria: Diagnosis of a psychotic disorder, bipolar disorder, anorexia nervosa, bulimia nervosa, substance use disorders within the past year (with the exception of caffeine and tobacco). Intelligent quotient less than 70 (if there is a clinical concern, subjects will be psychometrically assessed with the Slosson Intelligence Test, Revised).123 Positive urine drug screen at baseline Seizure history Any family history of epilepsy History of any treatment with electroconvulsive therapy or TMS Use of any investigational drug within 4 weeks of baseline Prior brain surgery Risk for increased intracranial pressure such as a brain tumor Head trauma with loss of consciousness Any true positive findings on the TMS safety screening form Pregnancy or suspected pregnancy Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the head-within 30 cm of the treatment coil excluding the mouth that cannot be safely removed (examples include cochlear implants, vagus nerve stimulators, deep brain stimulators, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes). Implanted medication pumps and cardiac pacemakers Any unstable medical condition Inability to adhere to the protocol

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Can Ozger

Phone

(507) 422-2605

ozger.can@mayo.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Jeremy Weiss

Phone

(507) 293-5659

weiss.jeremy@mayo.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Croarkin, DO, MS

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data will be uploaded and NIMH databases and shared as per NIMH and NIH policy

Citations:

PubMed Identifier

31207865

Citation

Sonmez AI, Camsari DD, Nandakumar AL, Voort JLV, Kung S, Lewis CP, Croarkin PE. Accelerated TMS for Depression: A systematic review and meta-analysis. Psychiatry Res. 2019 Mar;273:770-781. doi: 10.1016/j.psychres.2018.12.041. Epub 2018 Dec 7.

Results Reference

background

PubMed Identifier

30292987

Citation

Lewis CP, Camsari DD, Sonmez AI, Nandakumar AL, Gresbrink MA, Daskalakis ZJ, Croarkin PE. Preliminary evidence of an association between increased cortical inhibition and reduced suicidal ideation in adolescents treated for major depression. J Affect Disord. 2019 Feb 1;244:21-24. doi: 10.1016/j.jad.2018.09.079. Epub 2018 Sep 28.

Results Reference

background

PubMed Identifier

30031247

Citation

Croarkin PE, Nakonezny PA, Deng ZD, Romanowicz M, Voort JLV, Camsari DD, Schak KM, Port JD, Lewis CP. High-frequency repetitive TMS for suicidal ideation in adolescents with depression. J Affect Disord. 2018 Oct 15;239:282-290. doi: 10.1016/j.jad.2018.06.048. Epub 2018 Jul 18.

Results Reference

background

PubMed Identifier

29703993

Citation

Lewis CP, Nakonezny PA, Blacker CJ, Vande Voort JL, Port JD, Worrell GA, Jo HJ, Daskalakis ZJ, Croarkin PE. Cortical inhibitory markers of lifetime suicidal behavior in depressed adolescents. Neuropsychopharmacology. 2018 Aug;43(9):1822-1831. doi: 10.1038/s41386-018-0040-x. Epub 2018 Mar 14.

Results Reference

background

PubMed Identifier

31398593

Citation

Dhami P, Knyahnytska Y, Atluri S, Lee J, Courtney DB, Croarkin PE, Blumberger DM, Daskalakis ZJ, Farzan F. Feasibility and clinical effects of theta burst stimulation in youth with major depressive disorders: An open-label trial. J Affect Disord. 2019 Nov 1;258:66-73. doi: 10.1016/j.jad.2019.07.084. Epub 2019 Jul 30.

Results Reference

background

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation

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