Depressive EpisodePreNeSt2NCT05260086
Pre-mapping Networks for Brain Stimulation 2
A study testing Neuronavigated aiTBS in people with Depressive Episode and Major Depressive Disorder, run by University Medical Center Goettingen at 1 site in Germany.
Trial summary
The investigators compare the primary and secondary outcome measures using accelerated intermittent theta burst stimulation (aiTBS, 20 sessions active and 20 sessions sham in a counterbalanced crossover design) to treat depressive symptoms with 2 parallel arms of intervention: personalized (stimulation position based… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depressive Episode, Major Depressive Disorder
- What is being tested?
- Neuronavigated aiTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2019to 12 May 2022
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women between the ages of 18 and 60 years
- Diagnosis of major depressive disorder according to DSM 5 (F32.x according to ICD-10) or bipolar disorder (bipolar I or bipolar II) according to DSM 5 (F31.x according to ICD-10) and an acute depressive condition at the time of the initial examination in outpatient or inpatient treatment (e.g. Department of Psychiatry and Psychotherapy, UMG)
- Availability of informed consent to participate in the study, including the examinations and interventions
Who cannot join
- Neurological diseases, current or previous
- Other Axis I diagnoses that mimic the affective disorder, current or previous
- Physical illnesses that could be related to the affective symptoms (so-called organic causes)
- Illicit drug use in the past month
- Substance dependence, current or previous
- Physical illnesses which, depending on their type and severity, could interfere with the planned examinations, influence the parameters to be examined or endanger the test participant during the course of the examination
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- Medical contraindications against performing an MRT examination / rTMS application (such as metal parts in the body, e.g. implants, pacemakers, infusion pumps, metal splinters, etc.)
- Pregnancy
- Previously known cerebral-morphological abnormalities (e.g. tumor, lesion, etc.)
- Evidence or history of epilepsy
- Head trauma with a history of loss of consciousness
- Unwillingness to be informed of incidental findings
- Participation in an rTMS / EKT application within the last 8 weeks
- Lack of the ability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Laboratory of Systems Neuroscience and Imaging in Psychiatry (SNIP-Lab Göttingen)
Göttingen
About this study
Official title: Untersuchung Von Hirnnetzwerken Durch Nicht-invasive Transkranielle Magnetstimulation - Phase 2 (PreNeSt2)
The investigators compare the primary and secondary outcome measures using accelerated intermittent theta burst stimulation (aiTBS, 20 sessions active and 20 sessions sham in a counterbalanced crossover design) to treat depressive symptoms with 2 parallel arms of intervention: personalized (stimulation position based on participants' brain networks) vs conventional (stimulation in F3 position of the 10-20 EEG cap) aiTBS.
- Conditions
- Depressive Episode, Major Depressive Disorder
- Being tested
- Neuronavigated aiTBS
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuronavigated aiTBSDevice
Accelerated intermittent theta burst stimulation (aiTBS, 4 sessions per day with at least 20 minutes pause between sessions) in the left dorsolateral prefrontal cortex (DLPFC)
| Study group | Role | What they receive |
|---|---|---|
| Personalized aiTBS active - sham | Experimental | counterbalanced crossover with sham neuronavigated stimulation Receives: Device: Neuronavigated aiTBS |
| Conventional (F3) aiTBS active - sham | Active comparator | counterbalanced crossover with sham neuronavigated stimulation Receives: Device: Neuronavigated aiTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale (MADRS scores in units of scale)
Administer Rating Scale
Measured: 6 weeks
heart rate and its variability in RR slope and RMSSD values
Potential marker of treatment response
Measured: 4-6 weeks
Secondary outcomes (4)
Hamilton Rating Scale for Depression (HAMD-17 scores in units of scale)
Administer Rating Scale
Measured: 6 weeks
Beck Depression Inventory (BDI-2 scores in units of scale)
Self Rating Scale
Measured: 6 weeks
DMN decoupling / other networks in rho and z values
Potential markers of treatment response
Measured: 4-6 weeks
epi / genetic markers of neuroplasticity in ng
Potential markers of treatment response
Measured: 5-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start15 Apr 2019
- Primary completion12 May 2022
- Study completion12 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive EpisodeStudies 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
- Crossover
- Model description
- The investigators compare study outcomes using aiTBS in personalized stimulation targets vs conventional F3 stimulation targets in parallel arms, each arm controlled by its respective sham stimulation in a counterbalanced crossover design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Roberto Goya-Maldonado, University Medical Center Goettingen
- Investigators
- Roberto Goya-Maldonado, MD, Principal investigator, University Medical Center Göttingen (UMG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260086
- Sponsor's protocol ID
- 01759
- Acronym
- PreNeSt2
- Status last verified
- May 2022
- First submitted
- 10 Dec 2021
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Untersuchung Von Hirnnetzwerken Durch Nicht-invasive Transkranielle Magnetstimulation - Phase 2 (PreNeSt2)
- ClinicalTrials.gov ID
- NCT05260086
- Acronym / sponsor ID
- PreNeSt2 / 01759
- Conditions
- Depressive Episode, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 2 Mar 2022 (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 investigators compare the primary and secondary outcome measures using accelerated intermittent theta burst stimulation (aiTBS, 20 sessions active and 20 sessions sham in a counterbalanced crossover design) to treat depressive symptoms with 2 parallel arms of intervention: personalized (stimulation position based on participants' brain networks) vs conventional (stimulation in F3 position of the 10-20 EEG cap) aiTBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators compare study outcomes using aiTBS in personalized stimulation targets vs conventional F3 stimulation targets in parallel arms, each arm controlled by its respective sham stimulation in a counterbalanced crossover design.
| Arm | Type | Receives |
|---|---|---|
| Personalized aiTBS active - sham | Experimental | Device: Neuronavigated aiTBScounterbalanced crossover with sham neuronavigated stimulation |
| Conventional (F3) aiTBS active - sham | Active comparator | Device: Neuronavigated aiTBScounterbalanced crossover with sham neuronavigated stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men and women between the ages of 18 and 60 years
- Diagnosis of major depressive disorder according to DSM 5 (F32.x according to ICD-10) or bipolar disorder (bipolar I or bipolar II) according to DSM 5 (F31.x according to ICD-10) and an acute depressive condition at the time of the initial examination in outpatient or inpatient treatment (e.g. Department of Psychiatry and Psychotherapy, UMG)
- Availability of informed consent to participate in the study, including the examinations and interventions
Key exclusion criteria (14 listed)
- Neurological diseases, current or previous
- Other Axis I diagnoses that mimic the affective disorder, current or previous
- Physical illnesses that could be related to the affective symptoms (so-called organic causes)
- Illicit drug use in the past month
- Substance dependence, current or previous
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 |
|---|---|---|
| Neuronavigated aiTBSAccelerated intermittent theta burst stimulation (aiTBS, 4 sessions per day with at least 20 minutes pause between sessions) in the left dorsolateral prefrontal cortex (DLPFC) | Device | Conventional (F3) aiTBS active - sham, Personalized aiTBS active - sham |
Primary outcome
Montgomery-Åsberg Depression Rating Scale (MADRS scores in units of scale)
Time frame: 6 weeks
Administer Rating Scale
heart rate and its variability in RR slope and RMSSD values
Time frame: 4-6 weeks
Potential marker of treatment response
4 secondary outcomes
Hamilton Rating Scale for Depression (HAMD-17 scores in units of scale)
Time frame: 6 weeks
Beck Depression Inventory (BDI-2 scores in units of scale)
Time frame: 6 weeks
DMN decoupling / other networks in rho and z values
Time frame: 4-6 weeks
epi / genetic markers of neuroplasticity in ng
Time frame: 5-6 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 19 May 2022.
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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.
Roberto Goya-Maldonado, MD principal investigator
University Medical Center Göttingen (UMG)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuronavigated aiTBS in people with Depressive Episode and Major Depressive Disorder, run by University Medical Center Goettingen at 1 site in Germany.
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 3 inclusion and 14 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 19 May 2022. 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 Germany. 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?
Montgomery-Åsberg Depression Rating Scale (MADRS scores in units of scale) (time frame: 6 weeks). 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 19 May 2022.