rTMS Feasibility Study on Adolescent Depression Stimulation

Sponsor

Uppsala University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06126198

Collaborator

Uppsala University Hospital (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Unipolar Depression Bipolar Depression	Device: Repetitive Transcranial Magnetic Stimulation (rTMS)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open label studyOpen label study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

1 Hz rTMS Feasibility Study on Adolescent Treatment Resistant Major Depression

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active treatment Active treatment with Repetitive Transcranial Magnetic Stimulation (rTMS) according to clinical protocol.	Device: Repetitive Transcranial Magnetic Stimulation (rTMS) 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

Arm

Intervention/Treatment

Experimental: Active treatment

Active treatment with Repetitive Transcranial Magnetic Stimulation (rTMS) according to clinical protocol.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

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

Outcome Measures

Primary Outcome Measures

Inclusion rate - [two years]
Participant inclusion during the course of the study
Attrition rate [two years]
Participant drop-off during the course of the study

Secondary Outcome Measures

CGAS (Children's Global Assessment Scale) score [4 weeks, 6 weeks]
Children's Global Assessment Scale, score 1-100, where a high score indicates high functioning.
MADRS (Montgomery and Asberg Depression Rating Scale) score [at Baseline, 4 weeks, 6 weeks]
Montgomery and Asberg Depression Rating Scale, score 0-60, where a high score indicates symtoms of depression.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uppsala University	Uppsala		Sweden	75236

Sponsors and Collaborators

Uppsala University
Uppsala University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Uppsala University

ClinicalTrials.gov Identifier:

NCT06126198

Other Study ID Numbers:

Teen-TMS_UU2023

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 13, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Uppsala University

repetitive transcranial magnetic stimulation

Additional relevant MeSH terms:

Depression

Depressive Disorder

Depressive Disorder, Major

Bipolar Disorder

Study Results

No Results Posted as of Nov 13, 2023