RTMS Feasibility Study on Adolescent Depression Stimulation | NCT06126198

Studies
RTMS Feasibility Study on Adolescent Depression Stimulation

NCT06126198

Sponsor

Uppsala University

Status

Completed

Last Update Posted

Feb 4, 2025Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Major Depressive Disorder
Unipolar Depression
Bipolar Depression

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Nov 3, 2023

First Submission Date that Met QC Criteria

Nov 9, 2023

First Posted Date

Nov 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2025

Last Update Posted Date

Feb 4, 2025Actual

Name	Class
Uppsala University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an open-label study, in which all participants receives an active treatment with repetitive transcranial magnetic stimulation (rTMS) according to clinical protocol. The aim with this pilotstudy is to investigate the feasibility to perform a trial of low-frequency rTMS on treatment-resistant depression in adolescents. The study includes adolescents 13-19 years old, with average to severe depression.

Detailed Description

The intervention follows the identical clinical procedure used for adults. Initially, the resting motor threshold will be determined by stimulation over the motor cortex, by finding the minimal intensity that produces a motor response in the corresponding distal wrist muscles. The rTMS will be delivered with a powerMAG research ppTMS stimulator (Mag & More), and a figure-of -eight coil, PMD70-pCool (Mag & More). The intervention is within the intended use of this CE-marked medical device. The research participants will receive 1Hz rTMS with daily sessions on 20-30 consecutive week days. The magnetic pulses will be applied at 120% of the resting motor threshold with a figure-of-eight coil at a 45 degree angle towards the midline. The 1Hz rTMS protocol is applied 6 trains of 1-min duration separated by 30-sec inter-train "off" periods over the right DLPFC (F4 site 5 according to the10-20 system). The total duration of one 1 Hz rTMS session is 8 min 30 s.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active treatment	Experimental	Active treatment with Repetitive Transcranial Magnetic Stimulation (rTMS) according to clinical protocol.	Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Repetitive Transcranial Magnetic Stimulation (rTMS)	Device	rTMS induces local electrical currents in the stimulated neurons and has been shown to induce long-term inhibition or excitation of groups of neurons in treated cortical areas

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Inclusion rate -	Participant inclusion during the course of the study	two years
Attrition rate	Participant drop-off during the course of the study	two years

Secondary Outcomes

Measure	Description	Time Frame
CGAS (Children's Global Assessment Scale) score	Children's Global Assessment Scale, score 1-100, where a high score indicates high functioning.	4 weeks, 6 weeks
MADRS (Montgomery and Asberg Depression Rating Scale) score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent from parents and legal guardian
Age 13-19 years
Diagnosis of uni- or bipolar depression verified through a Mini International Neuropsychiatric Interview for children and adolescents (MINI-KID)
Treatment with at least two SSRIs at an adequate dose for at least 8 weeks

Exclusion Criteria:

Epilepsy or medical history of seizures
Conductive ferromagnetic or other magnetic sensitive metals implanted in the head or within 30 cm of the treatment coil
Implanted device that is activated or controlled in any way by physiological signals
Implanted medication pumps
Intracardiac lines (even if removed)
Active substance use disorder
Treatment with any medication that could lower the threshold for seizures
Usage of benzodiazepines both as prescribed drug and illegal use
Any condition that seriously increases the risk of non-compliance or loss of follow-up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Uppsala University		Uppsala		75236	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major
D003866	Depressive Disorder
D001714	Bipolar Disorder

Ancestor Terms

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders
D000068105	Bipolar and Related Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050781	Transcranial Magnetic Stimulation

Ancestor Terms

ID	Term
D055909	Magnetic Field Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided