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Clinical Trials/NL-OMON51625
NL-OMON51625Not yet recruitingNot Applicable

The effect of Deep Brain Stimulation on automatic freeze-fight-flight responses - Fear responses in the deep brain

Radboud Universiteit Nijmegen0 sites5 target enrollmentStarted: TBDLast updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
5

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18 to 99 (—)

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
  • - 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
  • 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

  • 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.

Investigators

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