Borderline Personality Disorder (BPD)SG2019-EXP2NCT06702215
Cortical Plasticity of the Tactile Mirror System in Borderline Personality Disorder
A study testing Cross-modal paired associative stimulation (cm-PAS) protocol in people with Borderline Personality Disorder (BPD), run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
Trial summary
People with borderline personality disorder (BPD) show alterations in the empathic abilities, which may involve the functioning of the mirror neuron system in the somatosensory domain. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder (BPD)
- What is being tested?
- Cross-modal paired associative stimulation (cm-PAS) protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteItaly
- Study dates
- 4 Sep 2023to 7 Nov 2025
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants: right handedness (Edinburgh Handedness Inventory; Oldfield, 1971)
- Patients group: clinical diagnosis of BPD. The severity of the symptoms will be assessed by means of the Zanarini rating scale for BPD (ZAN-BPD, Zanarini, 2003) and the Symptoms Check-list 90 Revised (SCL-90-R, Derogatis, 1994). Depressive symptoms will be evaluated with the Beck Depression Inventory II (BDI-II, Beck, 1988), impulsiveness with the Barratt Impulsiveness Scale (BIS, Patton, Stanford, \& Barratt, 1995), and alexithymia with the Toronto Alexithymia Scale (TAS-20, Bagby, Taylor, \& Parker, 1994). Moreover, interpersonal functioning will be evaluated with the Interpersonal Problems (IIP, Pilkonis, Kim, Proietti, \& Barkham, 1996), and attachment style will be assessed with the Attachment Style Questionnaire (Feeney, Noller, \& Hanrahan, 1994). Finally, the Childhood Trauma Questionnaire (CTQ; Bernstein \& Fink, 1998) will be administered for the assessment of traumatic experiences, and the Inventory of statements about self-injury (ISAS, Klonsky \& Glenn, 2009) for the evaluation of self-harm.
Who cannot join
- All participants: Contraindication to TMS (Rossi et al., 2021)
- All participants: Anamnesis or evidence of any central nervous system alteration
- Patients group: Comorbidity with schizophrenia and other psychotic disorders, according to DSM-5, and in case of unstable pharmacological therapy
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
Brescia, Brescia, 25125
About this study
People with borderline personality disorder (BPD) show alterations in the empathic abilities, which may involve the functioning of the mirror neuron system in the somatosensory domain. In the so-called Tactile Mirror System, the observation of a touch on someone else's body activates a cortical network also involved in tactile perception, including the primary somatosensory cortex. While alterations of mirror-like systems have been suggested in BPD, plasticity mechanisms within these systems are underexplored.
The present study aims to shed light on the possible neurophysiological alterations within the Tactile Mirror System in people with BPD, employing a non-invasive transcranial magnetic stimulation protocol, called cross-modal paired associative stimulation (cm-PAS), to induce brain plasticity.
Read the detailed description
While previous studies have suggested mirror system alterations in BPD, still little is known about the integrity of a basic neurophysiological mechanism such as brain plasticity within these systems. Considering that the development of mentalization and empathic abilities appears to rely on early associative learning and metaplasticity, it has been suggested that the pathophysiology of BPD may be associated with alterations in neuronal plasticity, mediated by N-methyl-D-aspartate (NMDA) neurotransmission; however, evidence is still lacking. Importantly, the integrity of plasticity mechanisms may represent a critical factor for the effectiveness of therapeutic interventions.
Paired associative stimulation (PAS) protocols represent a well-established tool to non-invasively induce brain plasticity effects in humans. To induce changes in synaptic efficacy, PAS protocols exploit the Hebbian learning rule and the concept of spike-timing dependent plasticity observed at the cellular level, namely that neural connections are strengthened (or weakened) in the case of repeated activations of the presynaptic neuron before the postsynaptic neuron (or vice-versa) in a critical time interval of a few tens of ms. In classical PAS protocols targeting the somatosensory system (S1-PAS), a peripheral electrical stimulus over the wrist (acting as presynaptic activation) is repeatedly paired with a transcranial magnetic stimulation (TMS) pulse over S1 in the contralateral hemisphere (acting as postsynaptic activation). Depending on the time interval between the two stimuli, the S1-PAS may induce long-term potentiation or depression (LTP- or LTD-like, respectively) effects, lasting up to 30 minutes after protocol delivery. In addition to neurophysiological effects (i.e., somatosensory evoked potential modulation), these plastic mechanisms have also been detected by exploiting behavioral measures of S1 functioning, such as tactile acuity.
PAS protocols have also been used to target multisensory integration networks: here, the peripheral and cortical stimuli belong to different systems. Recently, a cross-modal PAS (cm-PAS) has been developed in the visuo-tactile domain, with the aim of targeting the Tactile Mirror System. Compared to classical S1-PAS, in cm-PAS the peripheral electrical stimulus on the wrist is replaced by a visual stimulus of a hand being touched. The efficacy of the cm-PAS in inducing LTP-like mechanisms has been shown in a series of experiments, consisting of an increase in tactile acuity that was specific for the time interval between the visual stimulus and the TMS, for the site of cortical stimulation, and for the content of the visual stimulus. Moreover, cm-PAS modulated a neurophysiological correlate of S1 activity, namely, the amplitude of the P40 component of somatosensory-evoked potentials increased after cm-PAS. Overall, these findings are consistent with the hypothesis that when seeing a human touch on someone else's body, S1 is recruited by mirror-like mechanisms and can be involved in plasticity mechanisms.
Taking together the existing evidence, the present study aims to shed light on the neural basis of interpersonal dysfunction in BPD by bridging the gap between the literature on empathic alterations in BPD patients on the one hand and on the neurophysiological underpinnings of TaMS and its plastic properties in the healthy population on the other hand. Specifically, the integrity of plastic modulations within the Tactile Mirror System will be investigated in BPD patients, by employing the previously described cm-PAS.
The present study will involve BPD 24 patients and 24 healthy controls (HCs) undergoing two sessions of cm-PAS, i.e., an experimental session and a control session. BPD patients will be matched one-to-one with HCs for gender and age. The two groups will be compared in the cognitive dimensions of empathic abilities, measured by means of a self-report questionnaire (Questionnaire for Cognitive and Affective Empathy). To assess the effects of the cm-PAS, both groups will undergo a behavioral task involving visuo-tactile stimuli, before and after the cm-PAS protocol, and performance will be evaluated in terms of accuracy and reaction times.
- Conditions
- Borderline Personality Disorder (BPD)
- Being tested
- Cross-modal paired associative stimulation (cm-PAS) protocol
- Keywords
- transcranial magnetic stimulation, brain plasticity, paired associative stimulation, somatosensory domain, mirror neuron system, borderline personality disorder
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-modal paired associative stimulation (cm-PAS) protocolDevice
Also called PAS, TMS, transcranial magnetic stimulation
The cross-modal Paired Associative Stimulation (cm-PAS) will consist of a visual stimulus depicting a hand being touched repeatedly paired with a transcranial magnetic stimulation (TMS) pulse delivered over the right primary somatosensory area, for a total of 150 paired stimuli delivered at a fixed frequency of 0.1 Hz. The time interval between the visual-touch onset and the TMS pulse will be 20 ms for the experimental session and 100 ms for the control session.
| Study group | Role | What they receive |
|---|---|---|
| Experimental cm-PAS protocol followed by control cm-PAS protocol | Experimental | Participants will undergo the experimental cm-PAS protocol in the first session of the experiment, followed by the control cm-PAS protocol in the second session. The experimental and the control PAS protocols will differ in the timing of TMS delivery, one effective and the other one uneffective in inducing plastic effects, as shown by previous studies on healthy participants. Receives: Device: Cross-modal paired associative stimulation (cm-PAS) protocol |
| Control cm-PAS protocol followed by experimental cm-PAS protocol | Experimental | Participants will undergo the control cm-PAS protocol in the first session of the experiment, followed by the experimental cm-PAS protocol in the second session. The experimental and the control PAS protocols will differ in the timing of TMS delivery, one effective and the other one uneffective in inducing plastic effects, as shown by previous studies on healthy participants. Receives: Device: Cross-modal paired associative stimulation (cm-PAS) protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visuo-tactile performance
Behavioral performance will be obtained from an adapted version of the visuo-tactile spatial congruency task, already used in previous studies to investigate the tactile mirror system. In this task, pictures of a left and a right hand are presented on a screen in egocentric perspective, then, another hand in allocentric perspective appears on the screen and touches either the left or the right hand (i.e., visual touch). At the same time, participants receive a real touch on the left or the right hand, which can be spatially congruent or incongruent with respect to the visual touch. Participants will be asked to report the location of the real touch, i.e., on the left or on the right hand, as fast and accurately as possible, by pressing one of two buttons on a computer keyboard. Both reaction reaction times and accuracy will be considered as outcome measures.
Measured: Within 30 minutes before and after the cm-PAS protocol in each experimental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start4 Sep 2023
- Primary completion7 Nov 2025
- Study completion7 Nov 2025
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 Borderline Personality Disorder (BPD)Studies 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
- Both patients with BPD and healthy controls will undergo two experimental conditions, in counterbalanced order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnese Zazio, IRCCS Centro San Giovanni di Dio Fatebenefratelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702215
- Sponsor's protocol ID
- SG2019-EXP2
- Other IDs
- SG-2019-12370473
- Acronym
- SG2019-EXP2
- Status last verified
- Mar 2026
- First submitted
- 15 Nov 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * Behavioral performance (accuracy, reaction times) at the visuo-tactile spatial congruity task, before and after the experimental and the control cm-PAS protocol; * Empathic levels as indexed by self-report questionnaire
Publications
Zazio A, Guidali G, Maddaluno O, Miniussi C, Bolognini N. Hebbian associative plasticity in the visuo-tactile domain: A cross-modal paired associative stimulation protocol. Neuroimage. 2019 Nov 1;201:116025. doi: 10.1016/j.neuroimage.2019.116025. Epub 2019 Jul 17.
PubMed 31325642
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Plasticity of the Tactile Mirror System in Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT06702215
- Acronym / sponsor ID
- SG2019-EXP2 / SG2019-EXP2
- Conditions
- Borderline Personality Disorder (BPD)
- Keywords
- transcranial magnetic stimulation, brain plasticity, paired associative stimulation, somatosensory domain, mirror neuron system, borderline personality disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 7 Nov 2025 (actual)
- First posted
- 22 Nov 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.
People with borderline personality disorder (BPD) show alterations in the empathic abilities, which may involve the functioning of the mirror neuron system in the somatosensory domain. In the so-called Tactile Mirror System, the observation of a touch on someone else's body activates a cortical network also involved in tactile perception, including the primary somatosensory cortex. While alterations of mirror-like systems have been suggested in BPD, plasticity mechanisms within these systems are underexplored.
The present study aims to shed light on the possible neurophysiological alterations within the Tactile Mirror System in people with BPD, employing a non-invasive transcranial magnetic stimulation protocol, called cross-modal paired associative stimulation (cm-PAS), to induce brain plasticity.
Detailed description
While previous studies have suggested mirror system alterations in BPD, still little is known about the integrity of a basic neurophysiological mechanism such as brain plasticity within these systems. Considering that the development of mentalization and empathic abilities appears to rely on early associative learning and metaplasticity, it has been suggested that the pathophysiology of BPD may be associated with alterations in neuronal plasticity, mediated by N-methyl-D-aspartate (NMDA) neurotransmission; however, evidence is still lacking. Importantly, the integrity of plasticity mechanisms may represent a critical factor for the effectiveness of therapeutic interventions.
Paired associative stimulation (PAS) protocols represent a well-established tool to non-invasively induce brain plasticity effects in humans. To induce changes in synaptic efficacy, PAS protocols exploit the Hebbian learning rule and the concept of spike-timing dependent plasticity observed at the cellular level, namely that neural connections are strengthened (or weakened) in the case of repeated activations of the presynaptic neuron before the postsynaptic neuron (or vice-versa) in a critical time interval of a few tens of ms. In classical PAS protocols targeting the somatosensory system (S1-PAS), a peripheral electrical stimulus over the wrist (acting as presynaptic activation) is repeatedly paired with a transcranial magnetic stimulation (TMS) pulse over S1 in the contralateral hemisphere (acting as postsynaptic activation). Depending on the time interval between the two stimuli, the S1-PAS may induce long-term potentiation or depression (LTP- or LTD-like, respectively) effects, lasting up to 30 minutes after protocol delivery. In addition to neurophysiological effects (i.e., somatosensory evoked potential modulation), these plastic mechanisms have also been detected by exploiting behavioral measures of S1 functioning, such as tactile acuity.
PAS protocols have also been used to target multisensory integration networks: here, the peripheral and cortical stimuli belong to different systems. Recently, a cross-modal PAS (cm-PAS) has been developed in the visuo-tactile domain, with the aim of targeting the Tactile Mirror System. Compared to classical S1-PAS, in cm-PAS the peripheral electrical stimulus on the wrist is replaced by a visual stimulus of a hand being touched. The efficacy of the cm-PAS in inducing LTP-like mechanisms has been shown in a series of experiments, consisting of an increase in tactile acuity that was specific for the time interval between the visual stimulus and the TMS, for the site of cortical stimulation, and for the content of the visual stimulus. Moreover, cm-PAS modulated a neurophysiological correlate of S1 activity, namely, the amplitude of the P40 component of somatosensory-evoked potentials increased after cm-PAS. Overall, these findings are consistent with the hypothesis that when seeing a human touch on someone else's body, S1 is recruited by mirror-like mechanisms and can be involved in plasticity mechanisms.
Taking together the existing evidence, the present study aims to shed light on the neural basis of interpersonal dysfunction in BPD by bridging the gap between the literature on empathic alterations in BPD patients on the one hand and on the neurophysiological underpinnings of TaMS and its plastic properties in the healthy population on the other hand. Specifically, the integrity of plastic modulations within the Tactile Mirror System will be investigated in BPD patients, by employing the previously described cm-PAS.
The present study will involve BPD 24 patients and 24 healthy controls (HCs) undergoing two sessions of cm-PAS, i.e., an experimental session and a control session. BPD patients will be matched one-to-one with HCs for gender and age. The two groups will be compared in the cognitive dimensions of empathic abilities, measured by means of a self-report questionnaire (Questionnaire for Cognitive and Affective Empathy). To assess the effects of the cm-PAS, both groups will undergo a behavioral task involving visuo-tactile stimuli, before and after the cm-PAS protocol, and performance will be evaluated in terms of accuracy and reaction times.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Both patients with BPD and healthy controls will undergo two experimental conditions, in counterbalanced order.
| Arm | Type | Receives |
|---|---|---|
| Experimental cm-PAS protocol followed by control cm-PAS protocol | Experimental | Device: Cross-modal paired associative stimulation (cm-PAS) protocolParticipants will undergo the experimental cm-PAS protocol in the first session of the experiment, followed by the control cm-PAS protocol in the second session. The experimental and the control PAS protocols will differ in the timing of TMS delivery, one effective and the other one uneffective in inducing plastic effects, as shown by previous studies on healthy participants. |
| Control cm-PAS protocol followed by experimental cm-PAS protocol | Experimental | Device: Cross-modal paired associative stimulation (cm-PAS) protocolParticipants will undergo the control cm-PAS protocol in the first session of the experiment, followed by the experimental cm-PAS protocol in the second session. The experimental and the control PAS protocols will differ in the timing of TMS delivery, one effective and the other one uneffective in inducing plastic effects, as shown by previous studies on healthy participants. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All participants: right handedness (Edinburgh Handedness Inventory; Oldfield, 1971)
- Patients group: clinical diagnosis of BPD. The severity of the symptoms will be assessed by means of the Zanarini rating scale for BPD (ZAN-BPD, Zanarini, 2003) and the Symptoms Check-list 90 Revised (SCL-90-R, Derogatis, 1994). Depressive symptoms will be evaluated with the Beck Depression Inventory II (BDI-II, Beck, 1988), impulsiveness with the Barratt Impulsiveness Scale (BIS, Patton, Stanford, \& Barratt, 1995), and alexithymia with the Toronto Alexithymia Scale (TAS-20, Bagby, Taylor, \& Parker, 1994). Moreover, interpersonal functioning will be evaluated with the Interpersonal Problems (IIP, Pilkonis, Kim, Proietti, \& Barkham, 1996), and attachment style will be assessed with the Attachment Style Questionnaire (Feeney, Noller, \& Hanrahan, 1994). Finally, the Childhood Trauma Questionnaire (CTQ; Bernstein \& Fink, 1998) will be administered for the assessment of traumatic experiences, and the Inventory of statements about self-injury (ISAS, Klonsky \& Glenn, 2009) for the evaluation of self-harm.
Key exclusion criteria (3 listed)
- All participants: Contraindication to TMS (Rossi et al., 2021)
- All participants: Anamnesis or evidence of any central nervous system alteration
- Patients group: Comorbidity with schizophrenia and other psychotic disorders, according to DSM-5, and in case of unstable pharmacological therapy
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 |
|---|---|---|
| Cross-modal paired associative stimulation (cm-PAS) protocolAlso: PAS, TMS, transcranial magnetic stimulationThe cross-modal Paired Associative Stimulation (cm-PAS) will consist of a visual stimulus depicting a hand being touched repeatedly paired with a transcranial magnetic stimulation (TMS) pulse delivered over the right primary somatosensory area, for a total of 150 paired stimuli delivered at a fixed frequency of 0.1 Hz. The time interval between the visual-touch onset and the TMS pulse will be 20 ms for the experimental session and 100 ms for the control session. | Device | Control cm-PAS protocol followed by experimental cm-PAS protocol, Experimental cm-PAS protocol followed by control cm-PAS protocol |
Primary outcome
Visuo-tactile performance
Time frame: Within 30 minutes before and after the cm-PAS protocol in each experimental session
Behavioral performance will be obtained from an adapted version of the visuo-tactile spatial congruency task, already used in previous studies to investigate the tactile mirror system. In this task, pictures of a left and a right hand are presented on a screen in egocentric perspective, then, another hand in allocentric perspective appears on the screen and touches either the left or the right hand (i.e., visual touch). At the same time, participants receive a real touch on the left or the right hand, which can be spatially congruent or incongruent with respect to the visual touch. Participants will be asked to report the location of the real touch, i.e., on the left or on the right hand, as fast and accurately as possible, by pressing one of two buttons on a computer keyboard. Both reaction reaction times and accuracy will be considered as outcome measures.
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 27 Mar 2026.
- Background: PubMed 31325642Zazio A, Guidali G, Maddaluno O, Miniussi C, Bolognini N. Hebbian associative plasticity in the visuo-tactile domain: A cross-modal paired associative stimulation protocol. Neuroimage. 2019 Nov 1;201:116025. doi: 10.1016/j.neuroimage.2019.116025. Epub 2019 Jul 17.
- Individual participant dataSharing planned: Yes. * Behavioral performance (accuracy, reaction times) at the visuo-tactile spatial congruity task, before and after the experimental and the control cm-PAS protocol; * Empathic levels as indexed by self-report questionnaire
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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 Cross-modal paired associative stimulation (cm-PAS) protocol in people with Borderline Personality Disorder (BPD), run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
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 2 inclusion and 3 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 27 Mar 2026. 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 Italy. 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?
Visuo-tactile performance (time frame: Within 30 minutes before and after the cm-PAS protocol in each experimental session). 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 NCT06702215, 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 27 Mar 2026.