Determine the efficacy of atDCS as compared to ctDCS and sham stimulation in the improvement of executive functioning in PD-MCI.
ID
Source
Brief title
Condition
- Other condition
- Movement disorders (incl parkinsonism)
Synonym
Health condition
cognitieve stoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Efficacy of atDCS in the improvement of executive functioning in PD-MCI.
Secondary outcome
Network connectivity as a predictor and monitor of treatment response
Instrumental activities of daily living
Motor symptoms
Pain perception
Health-related quality of life
Mood
Background summary
Rationale: Parkinson*s disease (PD) has traditionally been considered a pure
motor system disorder, but it is now widely recognized to be a complex disorder
with diverse clinical features that also include non-motor manifestations like
neuropsychiatric disorders, cognitive dysfunction (mainly executive
dysfunction), dementia, and changes in pain perception.
As much as 26 to 34 percent of PD patients without dementia have been found to
meet criteria for Mild Cognitive Impairment that profoundly affects patient*s
every-daily-life functioning and quality of life. Considering the increase in
the incidence of PD-related mild cognitive impairment (PD-MCI) traditional
face-to-face cognitive rehabilitation strategies may not be cost-effective
strategies to maintain or enhance the integrity of cognitive functions in PD
patients. In this context, transcranial Direct Current Stimulation (tDCS) may
be a viable alternative. Anodal tDCS (or atDCS) causes membrane depolarization,
while cathodal tDCS (or ctDCS) hyperpolarizes the neural membrane. atDCS
reduces the threshold required for neuronal firing, and can hereby improve
cognitive functioning and neural efficiency.
Study objective
Determine the efficacy of atDCS as compared to ctDCS and sham stimulation in
the improvement of executive functioning in PD-MCI.
Study design
Double-blind RCT with three arms (atDCS, ctDCS, or placebo)
Intervention
Bipolar tDCS will be administered using two saline-soaked surface sponge
electrodes (area 7 x 5 cm2) and delivered by a battery-driven, constant-current
stimulator.
For atDCS, the anode will be placed above F3 (according to international 10-20
system of electrode placement) corresponding to the left dorsolateral
prefrontal cortex, and the cathode will be positioned above the contralateral
supraorbital region, at least 5 cm from the anode. DC stimulation will be
delivered for 20 minutes at 2 mA intensity (15 s ramp in and 15 s ramp out).
The montage will be reversed for cathodal tDCS. Sham stimulation will be
conducted with 5 s of tDCS applied at the onset to induce initial tingling
sensation consistent with real tDCS, after which the DC stimulator will be
deramped for 5 s.
At baseline (T0), patients will undergo cognitive assessment, detailed testing
of executive functioning and MEG recording will be performed, prior to
stimulation with atDCS, ctDCS, or sham. After stimulation, another assessment
of executive functioning and an MEG will be performed, in order to study the
immediate effects of stimulation (T1). On days 2, 3, and 4, stimulation (atDCS,
ctDCS, or sham) will be administered at the patient*s home, or at the hospital
if preferred by the patient. On day 5 (T2), patients will receive stimulation
followed by detailed assessment of executive functioning and MEG to study the
cumulative effects of the five consecutive stimulations on executive
functioning and network connectivity. Finally, to investigate whether tDCS has
longer-lasting effects, extensive cognitive assessment and assessment of
executive functioning will also be performed at 35 days follow-up (T3).
Study burden and risks
Measurement sessions, including preparation will take approximately 3 hours for
the first session on day 1 and 5, 20 minutes for day 2, 3, and 4 and 1,5 hour
for day 35. Informants fill in a questionnaire on day 1 and 35, which takes
2x30 minutes.
Transcranial Direct Current Stimulation is a non-invasive and safe technique. A
slight risk that has been reported is mood changes, therefore potential
subjects/patients with a diagnosed bipolar disorder82 or subjects/patients who
score more than 7 points on a depression questionnaire (HADS) are excluded from
this study, see exclusion criteria. Although never reported in clinical
studies, another theoretically low grade risk associated with tDCS may be
seizures. Therefore potential subjects/patients with a history of epileptic
seizures are excluded from this study, see exclusion criteria. Some non-harmful
discomforts that have been reported are: tingling, fatigue, headache and
nausea.
van der Boechorststraat 7
Amsterdam 1081BT
NL
van der Boechorststraat 7
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
1) Clinical diagnosis of PD according to the UK PD Brain Bank criteria60
2) PD-related mild cognitive impairment (PD-MCI)
3) If applicable, stable maintenance of their medication, including dopaminergic treatment, for at least 30 days prior to enrollment and throughout the study.;For the collection on data on instrumental activities of daily living
4) Presence of an informal informant
5) Ability of the informant to complete the questionnaire.
Exclusion criteria
1) Insufficient mastery of the Dutch language
2) Inability to understand test instructions in Dutch language
3) Any contra indications to tDCS like metallic implants (pacemaker etc.)
4) History of seizures
5) Substance abuse
6) Dementia
7) Major head trauma
8) Bipolar or psychiatric disorder
9) Signs of depression (Hospital Anxiety and Depression Scale, sub score D >7)
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 | NL52779.029.15 |