TMS in Borderline Personality Disorder Patients

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the potential effects of repetitive transcranial magnetic stimulation in the improvement of neuropsychological deficits and symptomatology in borderline personality disorder patients. Specially in cognitive flexibility, inhibition control and social cognition.

Clinical Trial Description

This is a randomized, parallel group clinical trial to evaluate the efficacy of two protocols of repetitive Transcranial Magnetic Stimulation (rTMS), the application will be over dorsolateral prefrontal cortex (DLPFC) right and left, in patients with borderline personality disorder. 40 ambulatory patients with a borderline personality disorder diagnosis from the National Institute of Psychiatry in México will be included. All Patients will be randomly assigned and will complete a total of 23 sessions rTMS, in any of two groups:

5 Hz Group.- This group will receive rTMS sessions, 5 per week during three weeks (acute treatment phase), and after that, one session a week for the next eight weeks (follow up). The rTMS will be applied over the left DLPFC at 5 Hz, 1500 pulses per session in 100% of Motor threshold

1 Hz Group.- This group will receive rTMS sessions, 5 per week during three weeks (acute treatment phase), and after that, one session a week for the next eight weeks (follow up).

The rTMS will be applied over the right DLPFC at 1 Hz, 900 pulses per session in 100% of Motor threshold All sessions will be applied with a "Dantec" transcranial magnetic stimulator. The affective, borderline and anxiety symptoms will be evaluated at baseline, and every 5 TMS sessions during the acute treatment phase, and once at the end of the 8-weeks follow up. In same form for neuropsychological evaluations .

Categorical variables will be described by percentages and frequencies. Continuous variables will be described by means and standard deviations. Treatment groups will be compared using Student's T test. Cognitive, anxiety, borderline and affective symptom scale scores between treatment groups will be compared using repeated measures ANOVA ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02273674
Study type	Interventional
Source	Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Contact
Status	Completed
Phase	N/A
Start date	January 2014
Completion date	February 2016

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04856449` - DBT Skills Plus EMDR for BPD and Trauma	N/A
Active, not recruiting	`NCT04587518` - Five Factor Model Treatment for Borderline Personality Disorder	N/A
Recruiting	`NCT05651295` - A Precision Medicine Approach to Target Engagement for Emotion Regulation	N/A
Completed	`NCT03677037` - The Short-Term MBT Project	Phase 3
Not yet recruiting	`NCT05989529` - Delving Into Borderline Personality Disorder Clinical Trial Experiences
Completed	`NCT02518906` - Evaluation of AIT Study	N/A
Completed	`NCT02068326` - MBT in Groups for Adolescents With BPD or Subthreshold BPD Versus TAU - the M-GAB Randomized Controlled Trial	N/A
Recruiting	`NCT04296604` - Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations	N/A
Terminated	`NCT02149823` - Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations	Phase 1
Completed	`NCT02108990` - Acetaminophen and Social Processes	Phase 2
Not yet recruiting	`NCT01683136` - Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Feasibility Study for the Treatment of Borderline Personality Disorder	N/A
Completed	`NCT01635556` - Evaluation of a Modified Dialectical Behavior Therapy Program	N/A
Completed	`NCT02988037` - Adapted Dialectical Behaviour Therapy for Adolescents With Deliberate Self-Harm: A Pre-post Observational Study	N/A
Completed	`NCT02397031` - Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder	N/A
Terminated	`NCT01103180` - Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder	Phase 2
Terminated	`NCT01212588` - Preliminary Trial of the Effect of Glucocorticoid Receptor Antagonist on Borderline Personality Disorder (BPD)	Phase 2
Terminated	`NCT00539188` - N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD	Phase 2
Recruiting	`NCT05398627` - Neurofeedback for Borderline Personality Disorder	N/A
Recruiting	`NCT03994510` - SHame prOpensity in bOrderline Personality Disorder	N/A
Recruiting	`NCT06005129` - Personality Change Study for Borderline Personality Disorder	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.