anxiety depression
Conditions
Interventions
None listed
Sponsors
Radboud Universiteit Nijmegen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will compare heart rate (bpm), skin conductance (mSiemens), and behavioural responses between *electrode switched-ON* vs *electrode switched-OFF* states within-subject (a) when fearful (vs. safe) faces are presented alongside aversive stimuli (mild electric shock to the finger) and (b) in anticipation of aversive (vs. safe) stimuli. | — |
Secondary
| Measure | Time frame |
|---|---|
| (a) Visual Analogue scales of pain and (b) scores from State Anxiety questionnaires will be compared within subject between *ON* and *OFF* states in order to see if this will be a confounding factor for the analysis for the primary and secondary objectives. | — |
Countries
Netherlands
Outcome results
None listed