NCT06702215

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2025

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

November 15, 2024

Last Update Submit

March 24, 2026

Conditions

Keywords

transcranial magnetic stimulationbrain plasticitypaired associative stimulationsomatosensory domainmirror neuron systemborderline personality disorder

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 30 minutes before and after the cm-PAS protocol in each experimental session

Study Arms (2)

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.

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.

Device: Cross-modal paired associative stimulation (cm-PAS) protocol

Interventions

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.

Also known as: PAS, TMS, transcranial magnetic stimulation
Control cm-PAS protocol followed by experimental cm-PAS protocolExperimental cm-PAS protocol followed by control cm-PAS protocol

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

Brescia, Brescia, 25125, Italy

Location

Related Publications (1)

  • 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.

    PMID: 31325642BACKGROUND

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Clinical ProtocolsTranscranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationMagnetic Field Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Both patients with BPD and healthy controls will undergo two experimental conditions, in counterbalanced order.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

November 15, 2024

First Posted

November 22, 2024

Study Start

September 4, 2023

Primary Completion

November 7, 2025

Study Completion

November 7, 2025

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

* 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

Shared Documents
ANALYTIC CODE
Time Frame
Upon acceptance of the scientific paper on study outcome.

Locations