AzTrials
AzTrials

Borderline Personality DisorderNCT02273674

TMS in Borderline Personality Disorder Patients

A study testing Left rTMS 5 Hz and Right r TMS 1 Hz in people with Borderline Personality Disorder, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Borderline Personality Disorder
What is being tested?
Left rTMS 5 Hz and Right r TMS 1 Hz
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteMexico
Study dates
Jan 2014to Feb 2016
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 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Mexico1 site

  • Instituto Nacional de Psiquiatria Ramon de la Fuente

    Mexico City, Mexico City, 14370

Other trials in Mexico

About this study

Official title: Repetitive Transcranial Magnetic Stimulation in Borderline Personality Disorder Patients. Effects in Clinical Measurements, Inhibition, Cognitive Flexibility, and Social Cognition Process

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.

Read the 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

Being tested
Left rTMS 5 Hz, Right r TMS 1 Hz
Keywords
Borderline Personality Disorder, Transcranial Magnetic Stimulation, Repetitive
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.

  • Left rTMS 5 HzDevice

    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 HzDevice

    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

Study groups in NCT02273674
Study groupRoleWhat they receive
Left rTMS 5 HzExperimentalThis 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
Receives: Device: Left rTMS 5 Hz
Right r TMS 1 HzExperimentalThis 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
Receives: Device: Right r TMS 1 Hz

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in BORDERLINE EVALUATION OF SEVERITY OVER TIME (BEST)

    The Borderline Evaluation of Severity Over Time (BEST) was developed to rate the thoughts, emotions, and behaviors typical of borderline personality disorder.

    Measured: Inclusion, after 15 days of treatment and at 8 weeks follow up

Secondary outcomes (5)

  1. Change from Baseline in Barratt impulsiveness scale

    The Barratt Impulsiveness Scale is a questionnaire designed to assess the personality/behavioral construct of impulsiveness.

    Measured: IInclusion, after 15 days of treatment and at 8 weeks follow up

  2. Change from Baseline in Hamilton Depression rating scale

    The Hamilton depression rating scale is a is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery

    Measured: Inclusion, after 15 days of treatment and at 8 weeks follow up

  3. Change from Baseline in Wisconsin card sorting test (WCST)

    WCST is used primarily to assess perseveration and abstract thinking, the WCST is also considered a measure of executive function because of its reported sensitivity to frontal lobe dysfunction.

    Measured: Inclusion, after 15 days of treatment and at 8 weeks follow up

  4. Change from Baseline in Stop Signal Task (SST)

    SST measuring response inhibition (impulse control). The subject must respond to an arrow stimulus, by touching either of two choices depending on the direction in which the arrow points. If an audio tone is present, the subject must inhibit that response.

    Measured: Inclusion, after 15 days of treatment and at 8 weeks follow up

  5. Change from Baseline in Reading the Mind in the Eyes Test

    The 'Reading the Mind in the Eyes' (Eyes) test is an advanced test of theory of mind. It is widely used to assess individual differences in social cognition and emotion recognition across different groups and cultures.

    Measured: Inclusion, after 15 days of treatment and at 8 weeks follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2016
  4. Study completionFeb 2016

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02273674
Sponsor's protocol ID
SC-14-1006
Status last verified
Feb 2016
First submitted
15 Oct 2014
Last updated
23 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24309885

  • 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.

    PubMed 28614492

Questions about this trial

What is this clinical trial studying?

A study testing Left rTMS 5 Hz and Right r TMS 1 Hz in people with Borderline Personality Disorder, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 1 site in Mexico.

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 3 inclusion and 7 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 23 Feb 2016. 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 Mexico. 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?

Change from Baseline in BORDERLINE EVALUATION OF SEVERITY OVER TIME (BEST) (time frame: Inclusion, after 15 days of treatment and at 8 weeks follow up). 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 NCT02273674, which also lists 2 linked publications.

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 23 Feb 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in