rTMS Feasibility Study on Adolescent Depression Stimulation

Major Depressive Disorder Clinical Trial

Official title:

1 Hz rTMS Feasibility Study on Adolescent Treatment Resistant Major Depression

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06126198
• Other study ID #: Teen-TMS_UU2023
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Unipolar Depression

Intervention

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

Locations

Country	Name	City	State
Sweden	Uppsala University	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inclusion rate -	Participant inclusion during the course of the study	two years
Primary	Attrition rate	Participant drop-off during the course of the study	two years
Secondary	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
Secondary	MADRS (Montgomery and Asberg Depression Rating Scale) score	Montgomery and Asberg Depression Rating Scale, score 0-60, where a high score indicates symtoms of depression.	at Baseline, 4 weeks, 6 weeks