To gain knowledge about the etiology of emotional changes after bilateral STN stimulation. And also to find out that the research design, where neuropsychological and psysiological aspects are combined, is useful in studying outcomes of STN…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
auditive startle reflex (latency, duration and peak of the amplitude EMG
activity per muscle)
tactile startle reflex (latency, duration and peak of the amplitude EMG
activity per muscle)
Psychogalvanic respons (difference between the minimum and maximum activity in
a period of four seconds after stimulus onset)
Affective reports on arousal and valence (Self Assessment Manikin)
Secondary outcome
General cognitive functioning (Mattis DRS)
Executive functions (letterfluency, Trail Making Test en Stroop)
Depression and/or anxiety (HADS)
Mood states (PANAS/POMS)
Motor symptoms (UPDRS part 3)
Background summary
Patients with advanced Parkinson`s disease often have response fluctuations and
dyskinesias. Bilateral subthalamic nucleus (STN) stimulation is a possibility
for reducing motor symptoms. However, negative outcomes have been reported,
like the presence of emotional changes.
A possible explanation is alternation of the emotional response after
STN stimulation. Lang, Bradley and Cuthbert (1990) define emotions as action
dispositions, which are organized around two dimensions: valence and arousal.
Emotional response can be measured by affective reports and physiological
activity, in particular the startle reflex and psychogalvanic response (PGR).
Patients with Parkinson`s disease have a reduced physiological response
to negative stimuli. Affective reports were similar to reports of controls
(Miller, 2004). Research of the emotional response after bilateral STN
stimulation has not been reported yet. Therefore the research question of this
study is: Is there a change of emotional response in Parkinson`s disease after
bilateral STN stimulation?
Study objective
To gain knowledge about the etiology of emotional changes after bilateral STN
stimulation. And also to find out that the research design, where
neuropsychological and psysiological aspects are combined, is useful in
studying outcomes of STN stimulation.
Study design
The study consists of a controlled, repeated measures design. Patients with
Parkinson`s disease who will undergo an STN stimulation will be examined
shortly before and two months after the surgery. Patients with Parkinson`s
disease who do not undergo surgery will be asked as controls. The auditory and
tactile startle reflex will be studied before and after surgery. Moreover
pleasant, unpleasant and neutral pictures will be showed. At the same time the
PGR is measured. Also, at each picture affective reports on valence and arousal
will be determined. Finally, tests concerning general cognitive functioning,
executive function, anxiety, depression, mood states and motor symptoms are
administered. Each evaluation will take at most two hours.
Study burden and risks
Each evaluation will take at most two hours. First light stress is caused by
auditory and tactile stimuli. This procedure contains no risks for the patient.
Moreover tests concerning general cognitive functioning, executive function,
anxiety, depression, mood states and motor symptoms are also administered.
postbus 22660
1100 DD Amsterdam
Nederland
postbus 22660
1100 DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- disease duration et least 5 years or more
- experimental condition: patiënts who undergo an STN stimulation
Exclusion criteria
- dementia (Mattis DRS < 120)
- other serious central nervous system diseases or other diseases.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14797.018.06 |