TMS in Borderline Personality Disorder Patients

NCT ID: NCT02273674

Last Updated: 2016-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-02-29

Brief 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.

Detailed 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

Conditions

Borderline Personality Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Left rTMS 5 Hz

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

Group Type: EXPERIMENTAL

Left rTMS 5 Hz

Intervention Type: DEVICE

The subjects will receive transcranial magnetic stimulation (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

Right r TMS 1 Hz

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

Group Type: EXPERIMENTAL

Right r TMS 1 Hz

Intervention Type: DEVICE

The subjects will receive transcranial magnetic stimulation (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

Interventions

Left rTMS 5 Hz

The subjects will receive transcranial magnetic stimulation (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

Intervention Type: DEVICE

Right r TMS 1 Hz

The subjects will receive transcranial magnetic stimulation (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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Nacional Autonoma de Mexico

OTHER

Sponsor Role: collaborator

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

OTHER

Sponsor Role: lead

Responsible Party

Julian Reyes Lopez

Medical doctor Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julian V Reyes, M.D.

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Psiquiatria

Locations

Instituto Nacional de Psiquiatria Ramon de la Fuente

Mexico City, Mexico City, Mexico

Countries

Mexico

References

Arbabi M, Hafizi S, Ansari S, Oghabian MA, Hasani N. High frequency TMS for the management of Borderline Personality Disorder: a case report. Asian J Psychiatr. 2013 Dec;6(6):614-7. doi: 10.1016/j.ajp.2013.05.006. Epub 2013 Jun 14.

Reference Type: BACKGROUND

PMID: 24309885 (View on PubMed)

Reyes-Lopez J, Ricardo-Garcell J, Armas-Castaneda G, Garcia-Anaya M, Arango-De Montis I, Gonzalez-Olvera JJ, Pellicer F. Clinical improvement in patients with borderline personality disorder after treatment with repetitive transcranial magnetic stimulation: preliminary results. Braz J Psychiatry. 2018 Jan-Mar;40(1):97-104. doi: 10.1590/1516-4446-2016-2112. Epub 2017 Jun 12.

Reference Type: DERIVED

PMID: 28614492 (View on PubMed)

Other Identifiers

SC-14-1006

Identifier Type: -

Identifier Source: org_study_id