Personality Disorder, BorderlineORIENTNCT04259554
OFC rTMS in Emotionally Unstable and Depressed Patients
A study testing OFC rTMS in people with Personality Disorder, Borderline and Personality Disorder; Unstable, run by University of Regensburg at 1 site in Germany.
Trial summary
Treatment of depression with conventional transcranial magnetic stimulation (rTMS) has shown high evidence using high-frequency left dorsolateral prefrontal cortex (DLPFC) stimulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Personality Disorder, Borderline, Personality Disorder; Unstable, Depression
- What is being tested?
- OFC rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 14 Feb 2020to 1 Oct 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICD-10: F60.30 or F60.31
- depressive symptoms and HAMD-21 score of at least 7
- sex: female and male
- residence in Germany and German speaking
- written informed consent
Who cannot join
- meeting the contraindications for transcranial magnetic stimulation (electric devices or metal implants in the body, e.g. cardiac pace maker, insulin pump)
- neurological disorders (e.g. cerebrovascular events, neurodegenerative disorder, epilepsy, brain malformation, severe head trauma)
- participation in another study parallel to the Trial
- other mental or somatic illness which is not compatible with participation according to the principal investigator
- pregnancy or breastfeeding period
- psychiatric confinement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Orbitofrontal Cortex Transcranial Magnetic Stimulation in Patients With Emotionally Unstable Personality Disorder and Depression
Treatment of depression with conventional transcranial magnetic stimulation (rTMS) has shown high evidence using high-frequency left dorsolateral prefrontal cortex (DLPFC) stimulation. Recently, it could be demonstrated that treatment of the right orbitofrontal cortex may be effective in patients who did not respond to conventional DLPFC rTMS. Orbitofrontal cortex (OFC) seem to be involved in the etiopathology of emotionally instable personality disorders. Thus, the present one-arm trial is a pilot study investigating if OFC rTMS is feasable, tolerable and effective.
- Being tested
- OFC rTMS
- Keywords
- rTMS
- Medical subject headings
- Borderline Personality Disorder, Personality Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OFC rTMSDevice
repetitive transcranial magnetic stimulation over right orbito-frontal cortex with 1Hz (360 pulses in 6 trains á 60 pulses with 30s intertrain-interval)
| Study group | Role | What they receive |
|---|---|---|
| OFC rTMS | Experimental | repetitive transcranial magnetic stimulation Receives: Device: OFC rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton depression rating scale (HDRS)
measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores
Measured: 4 weeks
Secondary outcomes (8)
Major Depression Inventory (MDI)
measurment of depressivity: 10 items with a range 0-50 and higher values indicating higher scores
Measured: 2 weeks, 4 weeks, 12 weeks
Clinical global impression (CGI)
measure of overall symptom severity and treatment response on a scale 1-7 with higher scores presenting more symptoms
Measured: 2 weeks, 4 weeks, 12 weeks
Depression module of the Patient health questionnaire (PHQ-D)
measurment of depressivity: 9 items with a range 0-27 and higher values indicating higher scores
Measured: 4 weeks, 12 weeks
Barratt impulsiveness Scale (BIS)
measurment of impulsivity: 30 items with a range 0-120 and higher values indicating higher scores
Measured: 4 weeks, 12 weeks
Numeric rating scale of pain
Numeric rating scale of pain (the higher the score the higher the pain) with a range 0-10
Measured: 2 weeks, 4 weeks
nicotine use
number of smoked cigarettes per day (the higher the value the higher the use)
Measured: 2 weeks, 4 weeks, 12 weeks
Hamilton depression rating scale (HDRS)
measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores
Measured: 2 weeks, 4 weeks, 12 weeks
Borderline Symptom List (BSL-23)
measurment of symptoms of borderline personality disorder: 23 items with a range 0-92 and higher values indicating higher scores
Measured: 2 weeks, 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start14 Feb 2020
- Primary completion1 Jul 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personality Disorder, BorderlineStudies 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
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berthold Langguth, MD, Ph.D., University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259554
- Sponsor's protocol ID
- 19-1615-101
- Acronym
- ORIENT
- Status last verified
- Dec 2022
- First submitted
- 5 Feb 2020
- Last updated
- 9 Dec 2022
- 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 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orbitofrontal Cortex Transcranial Magnetic Stimulation in Patients With Emotionally Unstable Personality Disorder and Depression
- ClinicalTrials.gov ID
- NCT04259554
- Acronym / sponsor ID
- ORIENT / 19-1615-101
- Keywords
- rTMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 6 Feb 2020 (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.
Treatment of depression with conventional transcranial magnetic stimulation (rTMS) has shown high evidence using high-frequency left dorsolateral prefrontal cortex (DLPFC) stimulation. Recently, it could be demonstrated that treatment of the right orbitofrontal cortex may be effective in patients who did not respond to conventional DLPFC rTMS. Orbitofrontal cortex (OFC) seem to be involved in the etiopathology of emotionally instable personality disorders. Thus, the present one-arm trial is a pilot study investigating if OFC rTMS is feasable, tolerable and effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OFC rTMS | Experimental | Device: OFC rTMSrepetitive transcranial magnetic stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ICD-10: F60.30 or F60.31
- depressive symptoms and HAMD-21 score of at least 7
- sex: female and male
- residence in Germany and German speaking
- written informed consent
Key exclusion criteria (6 listed)
- meeting the contraindications for transcranial magnetic stimulation (electric devices or metal implants in the body, e.g. cardiac pace maker, insulin pump)
- neurological disorders (e.g. cerebrovascular events, neurodegenerative disorder, epilepsy, brain malformation, severe head trauma)
- participation in another study parallel to the Trial
- other mental or somatic illness which is not compatible with participation according to the principal investigator
- pregnancy or breastfeeding period
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 |
|---|---|---|
| OFC rTMSrepetitive transcranial magnetic stimulation over right orbito-frontal cortex with 1Hz (360 pulses in 6 trains á 60 pulses with 30s intertrain-interval) | Device | OFC rTMS |
Primary outcome
Hamilton depression rating scale (HDRS)
Time frame: 4 weeks
measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores
8 secondary outcomes
Major Depression Inventory (MDI)
Time frame: 2 weeks, 4 weeks, 12 weeks
Clinical global impression (CGI)
Time frame: 2 weeks, 4 weeks, 12 weeks
Depression module of the Patient health questionnaire (PHQ-D)
Time frame: 4 weeks, 12 weeks
Barratt impulsiveness Scale (BIS)
Time frame: 4 weeks, 12 weeks
Numeric rating scale of pain
Time frame: 2 weeks, 4 weeks
nicotine use
Time frame: 2 weeks, 4 weeks, 12 weeks
Hamilton depression rating scale (HDRS)
Time frame: 2 weeks, 4 weeks, 12 weeks
Borderline Symptom List (BSL-23)
Time frame: 2 weeks, 4 weeks, 12 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 9 Dec 2022.
- 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 OFC rTMS in people with Personality Disorder, Borderline and Personality Disorder; Unstable, run by University of Regensburg 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 5 inclusion and 6 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 9 Dec 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?
Hamilton depression rating scale (HDRS) (time frame: 4 weeks). 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 9 Dec 2022.