Depression, UnipolarNCT06534684
The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression
A study testing Intermittent Theta Burst Stimulation in people with Depression, Unipolar and Depression Moderate, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The present project aims to assess the neurocognitive impact of a two-week once-a-day regimen of intermittent theta burst stimulation (iTBS) compared to sham iTBS, when targeting the left dorsolateral prefrontal cortex (LDLPFC) in clinically depressed outpatients. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Depression, Unipolar, Depression Moderate
- What is being tested?
- Intermittent Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- 12 Feb 2024to 12 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet the diagnostic criteria of at least a moderate depression
- The duration of the current depressive episode must have lasted more than 2 weeks but less than 2 years
- Drug therapy must have been stable for the last three weeks prior to the first treatment day with iTBS
- Patients must volunteer to provide informed consent, be able to follow the treatment schedule and have a satisfactory safety screening for iTBS and MRI
Who cannot join
- The current depressive episode is in the mild range
- The current episode fulfills the criteria for a major depressive episode requiring inpatient treatment and/or electroconvulsive therapy,
- The current depressive episode is clearly triggered by grief or a recent major stressful life event
- Bipolar disorder
- Borderline personality disorder
- Psychotic symptoms
Show all 17Show fewer
- Alcohol or substance abuse/addiction in the last 6 months
- Current eating disorders
- Obsessive- compulsive disorders
- Post-traumatic stress disorder
- A life-time medical history of seizure
- Neurological or neurosurgical pathologies
- Cardiac or systemic disease
- Metallic prosthetic material or foreign objects (pacemakers, prosthetic eye equipment, etc.)
- Autism
- Pregnancy
- Currently using of antipsychotic medication or benzodiazepines - or any medication that interferes with motor threshold excitability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
University Hospital North Norway
Tromsø, 9038
Ole Grønli, MD, PhD, ole.k.gronli@unn.no
About this study
Official title: The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression A Randomised Double-blind Sham-controlled Trial
The present project aims to assess the neurocognitive impact of a two-week once-a-day regimen of intermittent theta burst stimulation (iTBS) compared to sham iTBS, when targeting the left dorsolateral prefrontal cortex (LDLPFC) in clinically depressed outpatients. The study investigates the relationships between changes in cerebral measures and cognitive performance on an N-back task in relation to the antidepressive effect following iTBS.
Read the detailed description
The study is a randomized sham controlled double blind clinical trial in which the changes in cortical functions associated with the anti-depressive effect of two weeks of once-a-day neuronavigated iTBS over the left dorsolateral prefrontal cortex (LDLPFC) will be investigated in comparison to sham iTBS. Participants will be recruited prospectively, and the study is performed at a single university hospital. After written informed consent is obtained from eligible, volunteering patients, baseline measurements will be administrated, and the patient will be allocated to either sham or active iTBS once a day for 10 consecutive workdays. A total of three measurements will take place, namely at baseline prior to iTBS treatment, after two weeks with iTBS treatment (posttest) and four weeks after (follow-up). The primary outcome measures will be assessed from baseline to the posttest.
- Conditions
- Depression, Unipolar, Depression Moderate
- Being tested
- Intermittent Theta Burst Stimulation
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Theta Burst StimulationDevice
Intermittent Theta Burst Stimulation will be delivered with 120% of resting motor threshold with triplet 50 Hz bursts repeated at 5 Hz; 2 seconds on and 8 s off, 600 pulses per session with a total duration of 3 min 9 s. Treatment will be provided for 10 days for two consecutive weeks (except Saturdays and Sundays).
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Theta Burst Stimulation | Active comparator | Stimulation will be performed with a Mag \& More PowerMag EEG 100 system with a double PMD70 p-cool (fluid-cooled) figure-of-eight coil. Receives: Device: Intermittent Theta Burst Stimulation |
| Sham Intermittent Theta Burst Stimulation | Placebo comparator | Sham stimulation will be performed by the Mag \& More PowerMag EEG 100 system double PMD70 p-cool figure-of-eight coil Sham system. Receives: Device: Intermittent Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data from magnetic resonance imaging - white matter integrity
Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in anatomical measures of cerebral white matter integrity quantified by fractional anisotropy measured by diffusion tensor imaging (DTI) obtained from magnetic resonance imaging (MRI).
Measured: Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days
Data from magnetic resonance imaging - cortical thickness
Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in anatomical measures of thickness in cerebral gray matter thickness quantified by T1-weighted magnetic resonance imaging (MRI).
Measured: Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days
Data from magnetic resonance imaging - cerebral activity
Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in cerebral activity quantified by blood-oxygen-level-dependent (BOLD) responses measured by functional resonance imaging (fMRI).
Measured: Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days
Secondary outcomes (1)
Performance on a N-back cognitive test
Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in behavioral performance on a cognitive task measuring working memory and executive performance when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation.
Measured: Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start12 Feb 2024
- Primary completionJun 2025 (estimated)
- Study completion12 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, UnipolarStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- UiT The Arctic University of Norway
- Responsible party
- Principal investigator, Per Aslaksen, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534684
- Sponsor's protocol ID
- 715272
- Status last verified
- Aug 2024
- First submitted
- 25 May 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be made available to other researchers when the study has ended.
Publications
Orbo MC, Hoier S, Vangberg TR, Csifcsak G, Gronli OK, Aslaksen PM. The cerebral and cognitive changes after intermittent theta burst stimulation (iTBS) treatment for depression: study protocol for a randomized double-blind sham-controlled trial. Trials. 2024 Nov 11;25(1):752. doi: 10.1186/s13063-024-08606-8.
PubMed 39529199
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression A Randomised Double-blind Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT06534684
- Acronym / sponsor ID
- 715272
- Conditions
- Depression, Unipolar, Depression Moderate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- UiT The Arctic University of Norway
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- 12 Feb 2029 (estimated)
- First posted
- 2 Aug 2024 (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.
The present project aims to assess the neurocognitive impact of a two-week once-a-day regimen of intermittent theta burst stimulation (iTBS) compared to sham iTBS, when targeting the left dorsolateral prefrontal cortex (LDLPFC) in clinically depressed outpatients. The study investigates the relationships between changes in cerebral measures and cognitive performance on an N-back task in relation to the antidepressive effect following iTBS.
Detailed description
The study is a randomized sham controlled double blind clinical trial in which the changes in cortical functions associated with the anti-depressive effect of two weeks of once-a-day neuronavigated iTBS over the left dorsolateral prefrontal cortex (LDLPFC) will be investigated in comparison to sham iTBS. Participants will be recruited prospectively, and the study is performed at a single university hospital. After written informed consent is obtained from eligible, volunteering patients, baseline measurements will be administrated, and the patient will be allocated to either sham or active iTBS once a day for 10 consecutive workdays. A total of three measurements will take place, namely at baseline prior to iTBS treatment, after two weeks with iTBS treatment (posttest) and four weeks after (follow-up). The primary outcome measures will be assessed from baseline to the posttest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent Theta Burst Stimulation | Active comparator | Device: Intermittent Theta Burst StimulationStimulation will be performed with a Mag \& More PowerMag EEG 100 system with a double PMD70 p-cool (fluid-cooled) figure-of-eight coil. |
| Sham Intermittent Theta Burst Stimulation | Placebo comparator | Device: Intermittent Theta Burst StimulationSham stimulation will be performed by the Mag \& More PowerMag EEG 100 system double PMD70 p-cool figure-of-eight coil Sham system. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must meet the diagnostic criteria of at least a moderate depression
- The duration of the current depressive episode must have lasted more than 2 weeks but less than 2 years
- Drug therapy must have been stable for the last three weeks prior to the first treatment day with iTBS
- Patients must volunteer to provide informed consent, be able to follow the treatment schedule and have a satisfactory safety screening for iTBS and MRI
Key exclusion criteria (17 listed)
- The current depressive episode is in the mild range
- The current episode fulfills the criteria for a major depressive episode requiring inpatient treatment and/or electroconvulsive therapy,
- The current depressive episode is clearly triggered by grief or a recent major stressful life event
- Bipolar disorder
- Borderline personality disorder
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 |
|---|---|---|
| Intermittent Theta Burst StimulationIntermittent Theta Burst Stimulation will be delivered with 120% of resting motor threshold with triplet 50 Hz bursts repeated at 5 Hz; 2 seconds on and 8 s off, 600 pulses per session with a total duration of 3 min 9 s. Treatment will be provided for 10 days for two consecutive weeks (except Saturdays and Sundays). | Device | Intermittent Theta Burst Stimulation, Sham Intermittent Theta Burst Stimulation |
Primary outcome
Data from magnetic resonance imaging - white matter integrity
Time frame: Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days
Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in anatomical measures of cerebral white matter integrity quantified by fractional anisotropy measured by diffusion tensor imaging (DTI) obtained from magnetic resonance imaging (MRI).
Data from magnetic resonance imaging - cortical thickness
Time frame: Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days
Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in anatomical measures of thickness in cerebral gray matter thickness quantified by T1-weighted magnetic resonance imaging (MRI).
Data from magnetic resonance imaging - cerebral activity
Time frame: Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days
Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in cerebral activity quantified by blood-oxygen-level-dependent (BOLD) responses measured by functional resonance imaging (fMRI).
1 secondary outcome
Performance on a N-back cognitive test
Time frame: Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Derived from this study: PubMed 39529199Orbo MC, Hoier S, Vangberg TR, Csifcsak G, Gronli OK, Aslaksen PM. The cerebral and cognitive changes after intermittent theta burst stimulation (iTBS) treatment for depression: study protocol for a randomized double-blind sham-controlled trial. Trials. 2024 Nov 11;25(1):752. doi: 10.1186/s13063-024-08606-8.
- Individual participant dataSharing planned: Yes. Anonymised data will be made available to other researchers when the study has ended.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Theta Burst Stimulation in people with Depression, Unipolar and Depression Moderate, run by University Hospital of North Norway at 1 site in Norway.
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 17 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: looking for participants now, as of the sponsor's last update on 2 Aug 2024. 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 Norway. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Per M Aslaksen, PhD (77649234 ext. +47, per.aslaksen@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data from magnetic resonance imaging - white matter integrity (time frame: Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06534684, which also lists 1 linked publication.
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 2 Aug 2024.