To assess whether treatment with DBS can reduce or resolve TDD and if DBS can induce beneficial or side effects in particular psychiatric and or cognitive symptoms.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective, improvement on the movement disorder rating scales.
Secondary outcome
Secondary objectives improvement on the quality of life measured on the SF36
and the WHO-QoL including a cost effectiveness analysis, psychiatric stability
as measured on the BPRS and the MADRS and cognitive effects as measured with
the test battery used in the Nstaps trial.
Background summary
Tardive dyskinesia and dystonia (TDD) are severe side effects of dopamine
blocking agents, particularly antipsychotics. Deep brain stimulation (DBS) has
shown to be effective in the treatment of TDD in psychiatric patients, but only
reported in case reports and small clinical trials and with little attention to
possible psychiatric or cognitive complications or positive effect on
psychiatric symptoms.
Study objective
To assess whether treatment with DBS can reduce or resolve TDD and if DBS can
induce beneficial or side effects in particular psychiatric and or cognitive
symptoms.
Study design
A delayed onset double blind randomised controlled trial.
Intervention
All patients will be treated with DBS in the posteroventrolateral GPi.
Study burden and risks
Patients will be operated to receive a deep brain stimulator and receive the
standard care associated with this operation. This includes a number of pre-
and post-operative visits and a hospital stay of 7 days. The risks associated
with the surgery and anaesthesia are severe but the chance of developing them
is small. Stimulation dependent side-effects and risk*s are usually temporary
and easily remedied by adjusting the stimulation parameters. Little research
has been done towards the psychiatric risks associated with the operation and
stimulation. A review published by the investigators however, shows few
psychiatric complaints in both the short and the long term (Mentzel et al.
2012).
In addition questionnaires will be taken and videos will be made to enable
scoring of the movement disorder. This will take about 15 hours in 6 site
visits over 18 months in the immediate stimulation group and 18 hours in 8 site
visits over 21 months in the delayed onset group.
The review, published by the investigators, indicates an improvement of the
movement disorder after stimulation of 60-80% (Mentzel et al. 2012) on the
BFMDRS. The immediate stimulation and the delayed onset stimulation group will
benefit from stimulation. The immediate stimulation group will benefit from
improvement within a number of weeks post surgery. The delayed onset group will
benefit several weeks after stimulation is turned on.
Universiteitssingel 40
MAASTRICHT 6229 ER
NL
Universiteitssingel 40
MAASTRICHT 6229 ER
NL
Listed location countries
Age
Inclusion criteria
- Mental competence
- Age between 18 and 65 years
- A current or previous psychiatric illness that has been stable for at least 6 months
- Diagnosis of TDD
- TDD must be present for at least 12 months and impede physical and or social functioning
- BFMDRS >8 or AIMS >16
- Pharmacological treatments for TDD had insufficient effect or could not be tolerated
Exclusion criteria
- The patient does not fully comprehend the effects and potential side effects of brain surgery
- The patient is suicidal
- The patient has cognitive impairments
- The patient is severely mentally ill
- A neurological disease that explains the dyskinesia or dystonia
- Use of recreational drugs within the last 3 months
- Previous DBS or ablative stereotactic brain surgery
- General contraindications for stereotactic surgery and general anaesthesia
Design
Recruitment
Medical products/devices used
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 | NL43091.068.13 |