Major Depressive DisorderNCT06126198
RTMS Feasibility Study on Adolescent Depression Stimulation
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Major Depressive Disorder and Unipolar Depression, run by Uppsala University at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Major Depressive Disorder, Unipolar Depression, Bipolar Depression
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 1 Hz RTMS Feasibility Study on Adolescent Treatment Resistant Major Depression
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.
Read the 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.
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Keywords
- repetitive transcranial magnetic stimulation
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Active treatment with Repetitive Transcranial Magnetic Stimulation (rTMS) according to clinical protocol. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inclusion rate -
Participant inclusion during the course of the study
Measured: two years
Attrition rate
Participant drop-off during the course of the study
Measured: two years
Secondary outcomes (2)
CGAS (Children's Global Assessment Scale) score
Children's Global Assessment Scale, score 1-100, where a high score indicates high functioning.
Measured: 4 weeks, 6 weeks
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.
Measured: at Baseline, 4 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126198
- Sponsor's protocol ID
- Teen-TMS_UU2023
- Status last verified
- Jan 2025
- First submitted
- 3 Nov 2023
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1 Hz RTMS Feasibility Study on Adolescent Treatment Resistant Major Depression
- ClinicalTrials.gov ID
- NCT06126198
- Acronym / sponsor ID
- Teen-TMS_UU2023
- Keywords
- repetitive transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label study
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Active treatment with Repetitive Transcranial Magnetic Stimulation (rTMS) according to clinical protocol. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Active treatment |
Primary outcome
Inclusion rate -
Time frame: two years
Participant inclusion during the course of the study
Attrition rate
Time frame: two years
Participant drop-off during the course of the study
2 secondary outcomes
CGAS (Children's Global Assessment Scale) score
Time frame: 4 weeks, 6 weeks
MADRS (Montgomery and Asberg Depression Rating Scale) score
Time frame: at Baseline, 4 weeks, 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Major Depressive Disorder and Unipolar Depression, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inclusion rate - (time frame: two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.