TMS in Borderline Personality Disorder Patients

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Status: Completed

Conditions: Borderline Personality Disorder

Treatments: Device: Left rTMS 5 Hz; Device: Right r TMS 1 Hz

Study type: Interventional

Funder types: Other

Identifiers

NCT02273674

SC-14-1006

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of borderline personality disorder according to diagnostic and statistical manual of mental disorders IV text revision
• Treatment with selective inhibitors of serotonin reuptake
• Mass corporal index more than 19

Exclusion criteria

• Suicide risk or suicide attempt recent or actual
• History of epilepsy or seizures
• History of cranial trauma with loss awareness
• Intracranial or intraocular ferromagnetic devices, including skull prosthesis.
• Pregnant womens.
• Neurosurgery, cardiac pacemaker, lefthander
• Patients with psychotic symptoms, bipolar disorder or substance addiction.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Left rTMS 5 Hz

Experimental group

Description:

This group receive transcranial magnetic stimulation at 5 Hz of frequency over left dorsolateral prefrontal cortex. Once a day on monday to friday. Until receive 15 sessions. After this the subjects, will be received 8 more sessions of TMS, one session at week for next eight weeks

Treatment:

Device: Left rTMS 5 Hz

Right r TMS 1 Hz

Experimental group

Description:

This group receive transcranial magnetic stimulation at 1 Hz of frequency over right dorsolateral prefrontal cortex. Once a day on monday to friday. Until receive 15 sessions. After this the subjects, will be received 8 more sessions of TMS, one session at week for next eight weeks

Treatment:

Device: Right r TMS 1 Hz