The effect of Deep Brain Stimulation on automatic freeze-fight-flight responses
- Conditions
- anxietydepression10002861
- Registration Number
- NL-OMON51625
- Lead Sponsor
- Radboud Universiteit Nijmegen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 5
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Participant is willing to give informed consent for participation in the
study.
- Male or Female, aged 18-85 years.
- Participant is clinically fit.
- In the investigator*s opinion, is able to comply with all study requirements
(travel to the Donders Institute, repeatedly concentrate on a computer task for
±20 min., and perform the task via button presses).
- Additional inclusion criteria for participants with refractory neuropathic
pain:
o Diagnosed with chronic pain
o Fitted with Deep Brain Stimulation implants in the periaqueductal grey area
or the periventricular grey. By definition, in order to be eligible for the
implants for pain, patients will have failed pharmacotherapy (at least 3
classes of drugs) and have been through a pain management programme for at
least three years, including physiotherapy and psychology treatments.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
The participant may not enter the study if ANY of the following apply:
- Cardiac problems
- Anxiety disorders
- Other comorbidities that would preclude entry into the study, for example if
a patient had severe physical or mental impairment that would make it difficult
to sit and focus on the tasks.
- They feel their deep brain stimulator is not adequately controlling their
symptoms, or that turning it off for approximately 30 minutes will be
problematic.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>We will compare heart rate (bpm), skin conductance (mSiemens), and behavioural<br /><br>responses between *electrode switched-ON* vs *electrode switched-OFF* states<br /><br>within-subject (a) when fearful (vs. safe) faces are presented alongside<br /><br>aversive stimuli (mild electric shock to the finger) and (b) in anticipation of<br /><br>aversive (vs. safe) stimuli.</p><br>
- Secondary Outcome Measures
Name Time Method <p>(a) Visual Analogue scales of pain and (b) scores from State Anxiety<br /><br>questionnaires will be compared within subject between *ON* and *OFF* states in<br /><br>order to see if this will be a confounding factor for the analysis for the<br /><br>primary and secondary objectives.</p><br>