Characteristics and Training of Neural Responding in BPD

• Register: German Clinical Trials Register
• Last refreshed on: 27 May 2024
• Main ID: DRKS00003287
• Date of registration: 18/11/2011
• Prospective Registration: Yes
• Primary sponsor: Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health
• Public title: Characteristics and Training of Neural Responding in BPD
• Scientific title: Characteristics and Training of Neural Responding in BPD
• Date of first enrolment: 23/07/2012
• Target sample size: 120
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00003287
• Study type: observational
• Study design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: basic science

Countries of recruitment

Germany

Contacts

• Name: Christian Paret
• Affiliation: Central Institute of Mental Health

• Name: Gabriele Ende
• Affiliation: Department Neuroimaging, Central Institute of Mental Health

Key inclusion & exclusion criteria

Inclusion criteria: 1. Diagnosis of BPD following DSM4.
2. Remitted patients need to fullfill less than 5 DSM4criteria.
3. Healthy controls aged 18-45 without a history of psychiatric disorders.
Exclusion criteria: Exclusion criteria for all participants
• Pregnancy
• Lifetime diagnosis of psychotic disorder or bipolar I disorder
• Major depressive episode at the time of measurement
• Substance dependency in the preceding year
• Organic brain diseases
• Severe medical or neurological condition
• Antecedent cranial or brain injuries
• Metallic items in or on the body
• Left-handedness
• Claustrophobia
- Chronic non-healing wounds
- blood coagulation disorder
- medication with marcumar
- anamnestic brain lesion
- psychotropic medication within the last two weeks


Additional criteria for the healthy control group:
• Fulfilling more than one DSM IV criterion for BPD
• Any psychiatric disease



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

F60.31

F60.31

Intervention(s)

Group 1: Characterisation of neural response: 20 female patients with BPD
Neurofeedback training: 20 female patients with BPD
-In the first trial arm, 20 patients with BPD will be included. First, before the first measurement, diagnostic measures of axis 1 and 2 disorders will be obtained. BPD diagnosis will be obtained with the international personality disorder examination (IPDE), symptom severity will be measured with the borderline symptom list (BSL-95, Bohus et al. 2007). If inclusion criteria are met and informed consent is obtained, the participant will be included in the study.
Group 2: Subprojekt1 (chracterisation of neuronal response):
20 remitted female patients
Group 3: Characterisation of neural response:
20 female healthy controls
Neurofeedback training:
40 female healthy controls

Primary Outcome(s)

The BOLD response assessed with fMRI will be explored and better characterized. This should enhance the separation between healthy controls and BPD patients

Secondary Outcome(s)

We will test the hypothesis that BPD patients are able to learn to control their emotional response by an fMRI neurofeedback training.

Source(s) of Monetary Support

Deutsche Forschungsgemeinschaft

Haushaltsmittel

Ethics review

Status: Approved
Approval date: 22/02/2011
Contact:

Results

• URL: http://drks.de/search/en/trial/DRKS00003287#studyResults