Borderline Personality DisorderIMPULSENCT05942651
Impulsivity With Borderline Personality Disorder/tMS
A study testing Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 4 ms intervals. and Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 100 ms intervals in people with Borderline Personality Disorder, run by Hôpital le Vinatier at 1 site in France.
Trial summary
This is a prospective, randomized, double-blind, parallel-group controlled trial. The aim of this research project is to compare the clinical benefits achieved in patients with Borderline Personality Disorder (BPD) following two types of intervention: ccPAS active or ccPAS sham. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 4 ms intervals. and Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 100 ms intervals
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2024to 20 Sep 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of BPD (established by a psychiatrist and confirmed in a structured interview using the MINI) based on the Diagnostic and Statistical Manual of Mental Disorders (DSM V).
Who cannot join
- Contraindications to TMS/MRI (pacemakers or other devices likely to interfere with the magnetic field).
- Pregnant or breast-feeding women.
- Ongoing anxiolytic treatment (benzodiazepines), neuroleptic treatment or anticonvulsants acting on GABAergic transmission ; 24 hours prior to the protocol.
- Diagnosis of other chronic psychiatric pathology including bipolar disorder type I or II and addictions (except tobacco).
- Protective measure (curatorship or guardianship)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
sartelet lydie contact
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Le Vinatier
Bron, AURA, 69678 CEDEX
POULET EMMANUEL, PUPH, 0033437915120, emmanuel.poulet@chu-lyon.fr
VIAL VERONIQUE, 0033437915531, veronique.vial@ch-le-vinatier.fr
About this study
Official title: Reduction of Impulsivity in Patients With Borderline Personality Disorder Using Dual-site Transcranial Magnetic Stimulation
This is a prospective, randomized, double-blind, parallel-group controlled trial. The aim of this research project is to compare the clinical benefits achieved in patients with Borderline Personality Disorder (BPD) following two types of intervention: ccPAS active or ccPAS sham.
Read the detailed description
Borderline personality disorder (BPD) is a mental disorder characterized by unstable interpersonal relationships, emotional lability and marked impulsivity. The latter manifests itself through risky behaviors such as substance abuse, self-harm and suicidal behavior.
Studies suggest that 1.3% of the general population suffers from BPD. However, in clinical settings, BPD patients represent 20% of all inpatients in psychiatric wards and up to 50% of patients hospitalized in emergency departments following a suicide attempt (SA). Moreover, it is estimated that nearly 84% of BPD patients will make at least one SA in their lifetime and up to 10% of them will die by suicide, a rate 50 times higher than the general population. Impulsivity, reflected in difficulties holding back action or stopping an action that has already begun, is one of the key symptoms of BPD.
Recent advances in non-invasive brain stimulation have led to the emergence of a new stimulation protocol known as Paired Cortico-Cortical Associative Stimulation (ccPAS), which consists of repeating paired stimulations using two TMS coils placed respectively on two cortical regions of interest. Paired stimulations' repetition induces plasticity by strengthening synaptic connectivity between the two targeted regions.
The aim of this project is to test the efficacy of a ccPAS protocol in enhancing effective connectivity between the IFC and pre-SMA in order to reduce impulsivity in BPD patients.
The Sponsor hypothesized that one ccPAS session, using two coils simultaneously, targeting the IFC and pre-SMA with a 'physiological' inter-stimulus interval of 4ms will improve motor inhibition abilities (reduce SSRT), compared to the group receiving 'control' ccPAS (100ms inter-stimulus interval (ccPAS100-ms)).
- Conditions
- Borderline Personality Disorder
- Being tested
- Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 4 ms intervals., Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 100 ms intervals
- Keywords
- Borderline Personality Disorder, brain stimulation, impulsivity
- Medical subject headings
- Borderline Personality Disorder, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 4 ms intervals.Device
The first stimulation will be applied to the IFC and the second to the pre-SMA, with an interstimulation interval set at 4 ms. A total of 180 stimulation pairs will be delivered every 2 s. (5Hz) for a total duration of 15 minutes at an intensity of 120% of rMT
Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 100 ms intervalsDevice
The first stimulation will be applied to the IFC and the second to the pre-SMA, with an interstimulation interval set at 100 ms. A total of 180 stimulation pairs will be delivered every 2 s. (5Hz) for a total duration of 15 minutes at an intensity of 120% of rMT
| Study group | Role | What they receive |
|---|---|---|
| active ccPAS4-ms | Active comparator | Device: Magstim BiStim 2002 (The Magstim Company Ltd., Spring Gardens, Whitland, UK) and two small coils (40mm, figure-of-eight coils, Alpha B.I).
Coil 1 was positioned over right IFC at a 20° angle to the coronal plane with the handle pointing anteriorly, and coil 2 was positioned over right pre- SMA perpendicular to the midline.
The first stimulation will be applied to the IFC and the second to the pre-SMA, with an interstimulation interval set at 4 ms. A total of 180 stimulation pairs will be delivered every 2 s. (5Hz) for a total duration of 15 minutes at an intensity of 120% of rMT Receives: Device: Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 4 ms intervals. |
| Control condition ccPAS100-ms. | Sham comparator | Device: Magstim BiStim 2002 (The Magstim Company Ltd., Spring Gardens, Whitland, UK) and two small coils (40mm, figure-of-eight coils, Alpha B.I).
Coil 1 was positioned over right IFC at a 20° angle to the coronal plane with the handle pointing anteriorly, and coil 2 was positioned over right pre- SMA perpendicular to the midline.
The first stimulation will be applied to the IFC and the second to the pre-SMA, with an interstimulation interval set at 100 ms. A total of 180 stimulation pairs will be delivered every 2 s. (5Hz) for a total duration of 15 minutes at an intensity of 120% of rMT Receives: Device: Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 100 ms intervals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant reduction in reaction time of the Emotional Stop Signal (SSRT) for the ccPAS4-ms group compared to the ccPAS100-ms sham group
The ability to inhibit an action (motor inhibition) is quantified using a 'Stop Signal' task in which the reaction time required to inhibit the action (SSRT) is calculated. The longer the SSRT, the poorer the ability to inhibit an action and the greater the motor impulsivity
Measured: 2 times: Outcome measure will be assessed: immediately before the ccPAS protocol and immediately after the ccPAS protocol, for both groups
Secondary outcomes (4)
Increased effective inhibitory connectivity within the fronto-striatal network (DLPFC-M1), intracortical inhibition (short and long interval) and cortical silent period for the ccPAS4-ms group, when compared with the ccPAS100-ms group
Dual-site transcranial magnetic stimulation (TMS) can be used to probe effective connectivity between the left DLPFC and the left M1 (Wang et al. 2021). Conditioned motor evoked potential (MEP) amplitude evoked by dual-site TMS and measured with surface electromyography (EMG) is compared to MEP amplitude evoked by TMS applied over M1 alone.
Measured: 2 times: Outcome measure will be assessed: immediately before the ccPAS protocol and immediately after the ccPAS protocol, for both groups
Levels of intracortical inhibition within M1.
Paired-pulse TMS provides a non-invasive method to study intracortical inhibitory circuits. Short-interval intracortical inhibition (SICI) is a well-established paired-pulse measure of inhibitory circuitry within the M1 area. SICI results from a subthreshold conditioning stimulus (CS) followed 3.5 ms later by a suprathreshold test stimulus (TS) delivered through the same coil over M1. This measurement will be correlated with the other inhibition measurements (SSRT at baseline and duration of the silent period) to provide an overall view of the efficacy/inefficacy of this inhibitory system in patients with borderline personality disorder.
Measured: 1 time: Measured before the ccPAS protocol, in both groups.
Duration of cortical silence period (in ms).
Single-pulse TMS applied over M1 during a voluntary contraction elicited a motor evoked potential followed immediately by a period of EMG silence that has been assumed to reflect intracortical inhibition. This measurement will be correlated with the other inhibition measurements (SSRT at baseline and SICI) to provide an overall view of the efficacy/inefficacy of this inhibitory system in patients with borderline personality disorder.
Measured: 1 time: Measured before the ccPAS protocol, in both groups
Cognitive task manipulating environment-emotion-behavior interactions.
The task is framed to participants as being a fish gathering algae while predators might approach for which they need to check and if appropriate hide. The task features differentially evoke emotions of stress and excitement. Self-reported stress and threat-avoidance behaviors during the task will be measured.
Measured: 1 time: Measured before the ccPAS protocol, in both groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start8 Jan 2024
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, double-blind, parallel-group controlled trial with two arms.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942651
- Sponsor's protocol ID
- 2023-A00772-43
- Acronym
- IMPULSE
- Status last verified
- Jun 2023
- First submitted
- 4 Jul 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Impulsivity in Patients With Borderline Personality Disorder Using Dual-site Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT05942651
- Acronym / sponsor ID
- IMPULSE / 2023-A00772-43
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline Personality Disorder, brain stimulation, impulsivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Sep 2027 (estimated)
- First posted
- 12 Jul 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 a prospective, randomized, double-blind, parallel-group controlled trial. The aim of this research project is to compare the clinical benefits achieved in patients with Borderline Personality Disorder (BPD) following two types of intervention: ccPAS active or ccPAS sham.
Detailed description
Borderline personality disorder (BPD) is a mental disorder characterized by unstable interpersonal relationships, emotional lability and marked impulsivity. The latter manifests itself through risky behaviors such as substance abuse, self-harm and suicidal behavior.
Studies suggest that 1.3% of the general population suffers from BPD. However, in clinical settings, BPD patients represent 20% of all inpatients in psychiatric wards and up to 50% of patients hospitalized in emergency departments following a suicide attempt (SA). Moreover, it is estimated that nearly 84% of BPD patients will make at least one SA in their lifetime and up to 10% of them will die by suicide, a rate 50 times higher than the general population. Impulsivity, reflected in difficulties holding back action or stopping an action that has already begun, is one of the key symptoms of BPD.
Recent advances in non-invasive brain stimulation have led to the emergence of a new stimulation protocol known as Paired Cortico-Cortical Associative Stimulation (ccPAS), which consists of repeating paired stimulations using two TMS coils placed respectively on two cortical regions of interest. Paired stimulations' repetition induces plasticity by strengthening synaptic connectivity between the two targeted regions.
The aim of this project is to test the efficacy of a ccPAS protocol in enhancing effective connectivity between the IFC and pre-SMA in order to reduce impulsivity in BPD patients.
The Sponsor hypothesized that one ccPAS session, using two coils simultaneously, targeting the IFC and pre-SMA with a 'physiological' inter-stimulus interval of 4ms will improve motor inhibition abilities (reduce SSRT), compared to the group receiving 'control' ccPAS (100ms inter-stimulus interval (ccPAS100-ms)).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, double-blind, parallel-group controlled trial with two arms.
| Arm | Type | Receives |
|---|---|---|
| active ccPAS4-ms | Active comparator | Device: Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 4 ms intervals.Device: Magstim BiStim 2002 (The Magstim Company Ltd., Spring Gardens, Whitland, UK) and two small coils (40mm, figure-of-eight coils, Alpha B.I). Coil 1 was positioned over right IFC at a 20° angle to the coronal plane with the handle pointing anteriorly, and coil 2 was positioned over right pre- SMA perpendicular to the midline. The first stimulation will be applied to the IFC and the second to the pre-SMA, with an interstimulation interval set at 4 ms. A total of 180 stimulation pairs will be delivered every 2 s. (5Hz) for a total duration of 15 minutes at an intensity of 120% of rMT |
| Control condition ccPAS100-ms. | Sham comparator | Device: Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 100 ms intervalsDevice: Magstim BiStim 2002 (The Magstim Company Ltd., Spring Gardens, Whitland, UK) and two small coils (40mm, figure-of-eight coils, Alpha B.I). Coil 1 was positioned over right IFC at a 20° angle to the coronal plane with the handle pointing anteriorly, and coil 2 was positioned over right pre- SMA perpendicular to the midline. The first stimulation will be applied to the IFC and the second to the pre-SMA, with an interstimulation interval set at 100 ms. A total of 180 stimulation pairs will be delivered every 2 s. (5Hz) for a total duration of 15 minutes at an intensity of 120% of rMT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of BPD (established by a psychiatrist and confirmed in a structured interview using the MINI) based on the Diagnostic and Statistical Manual of Mental Disorders (DSM V).
Key exclusion criteria (5 listed)
- Contraindications to TMS/MRI (pacemakers or other devices likely to interfere with the magnetic field).
- Pregnant or breast-feeding women.
- Ongoing anxiolytic treatment (benzodiazepines), neuroleptic treatment or anticonvulsants acting on GABAergic transmission ; 24 hours prior to the protocol.
- Diagnosis of other chronic psychiatric pathology including bipolar disorder type I or II and addictions (except tobacco).
- Protective measure (curatorship or guardianship)
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 |
|---|---|---|
| Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 4 ms intervals.The first stimulation will be applied to the IFC and the second to the pre-SMA, with an interstimulation interval set at 4 ms. A total of 180 stimulation pairs will be delivered every 2 s. (5Hz) for a total duration of 15 minutes at an intensity of 120% of rMT | Device | active ccPAS4-ms |
| Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 100 ms intervalsThe first stimulation will be applied to the IFC and the second to the pre-SMA, with an interstimulation interval set at 100 ms. A total of 180 stimulation pairs will be delivered every 2 s. (5Hz) for a total duration of 15 minutes at an intensity of 120% of rMT | Device | Control condition ccPAS100-ms. |
Primary outcome
Significant reduction in reaction time of the Emotional Stop Signal (SSRT) for the ccPAS4-ms group compared to the ccPAS100-ms sham group
Time frame: 2 times: Outcome measure will be assessed: immediately before the ccPAS protocol and immediately after the ccPAS protocol, for both groups
The ability to inhibit an action (motor inhibition) is quantified using a 'Stop Signal' task in which the reaction time required to inhibit the action (SSRT) is calculated. The longer the SSRT, the poorer the ability to inhibit an action and the greater the motor impulsivity
4 secondary outcomes
Increased effective inhibitory connectivity within the fronto-striatal network (DLPFC-M1), intracortical inhibition (short and long interval) and cortical silent period for the ccPAS4-ms group, when compared with the ccPAS100-ms group
Time frame: 2 times: Outcome measure will be assessed: immediately before the ccPAS protocol and immediately after the ccPAS protocol, for both groups
Levels of intracortical inhibition within M1.
Time frame: 1 time: Measured before the ccPAS protocol, in both groups.
Duration of cortical silence period (in ms).
Time frame: 1 time: Measured before the ccPAS protocol, in both groups
Cognitive task manipulating environment-emotion-behavior interactions.
Time frame: 1 time: Measured before the ccPAS protocol, in both groups.
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 7 Mar 2024.
- 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.
sartelet lydie contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 4 ms intervals. and Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 100 ms intervals in people with Borderline Personality Disorder, run by Hôpital le Vinatier at 1 site in France.
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 1 inclusion and 5 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 7 Mar 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 France. 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 POULET Emmanuel, PUPH (0437915565 ext. +33, emmanuel.poulet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant reduction in reaction time of the Emotional Stop Signal (SSRT) for the ccPAS4-ms group compared to the ccPAS100-ms sham group (time frame: 2 times: Outcome measure will be assessed: immediately before the ccPAS protocol and immediately after the ccPAS protocol, for both groups). 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 7 Mar 2024.