To evaluate the effects of tDCS on information processing speed in comparison to sham tDCS in patients after stroke with ascertained reduced processing speed. A proof of principle study.
ID
Source
Brief title
Condition
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary research outcome: reaction time measured during a test of attentional
performance (TAP-test) which consists of a divided attention task and a go - no
go task at two different levels.
Secondary outcome
Secondary outcome: differences in performance of time pressure activities in
normal life and the perceived consequences of slow information processing speed
before and after tDCS measured by the mental slowness observation test (MSOT)
and mental slowness questionnaire (MSQ).
Background summary
Cognitive deficits are common after stroke. There is evidence from the
scientific literature to suggest that transcranial direct current stimulation
(tDCS) can enhance cognitive functioning and thereby ameliorate the outcome of
the rehabilitation of cognitive deficits. tDCS is a non-invasive and safe brain
stimulation method that applies weak direct currents (1-2 mA) to the brain
through electrodes applied to the skull to influence cortical excitability
levels. The aim of this study is to test the hypothesis that tDCS as compared
to sham tDCS will enhance reaction times in patients with reduced processing
speed after stroke.
Study objective
To evaluate the effects of tDCS on information processing speed in comparison
to sham tDCS in patients after stroke with ascertained reduced processing
speed. A proof of principle study.
Study design
A randomized sham-controlled double blind within subjects design.
Intervention
tDCS will be delivered by a battery-driven constant DC current stimulator
(Eldith DC Stimulator (CE 0118), Ilmenau) using two 5-7 cm electrodes (35 cm2)
and one 10-10 cm return electrode (100 cm2) in saline-soaked synthetic sponge
at an electric current intensity of 1 mA (peak-to-peak) for a maximum of 20
minutes.
Study burden and risks
The currently proposed tDCS procedure and experiment does not carry any
significant risks. Potential side-effects of tDCS are light tingling, itching
or burning sensations under the electrodes, light headache and/or fatigue.
These are mild discomforts that respond promptly to common analgesics.
Volunteers can withdraw from the study at any given time and there are no
direct benefits for the participants. The novel insights will broaden our
understanding of the brain and may contribute to the feasibility and
development of possible new ways to improve reaction time using non-invasive
brain modulation.
Heijenoordseweg 5
Arnhem 6813 GG
NL
Heijenoordseweg 5
Arnhem 6813 GG
NL
Listed location countries
Age
Inclusion criteria
• Between 18 - 65 years of age
• Ischemic cerebral infarction
• Postonset of > 4 months (chronic stage)
• Reduced processing speed as assessed by neuropsychological assessment
• Willingness and ability to give written informed consent and willingness and ability to understand the nature and content, to participate and to comply with the study requirements.
Exclusion criteria
• History of previous stroke
• Pre-existent cognitive problems
• Severe aphasia (unable to understand instructions)
• Neglect
• Hemianopia
• Average use of more than 3 alcoholic beverages daily
• Use of psychotropic medication or recreational drugs
• Skin disease
• Pregnancy
• Serious head trauma or brain surgery
• Neurological or psychiatric disorders (other than stroke)
• Large or ferromagnetic metal parts in the head (except for a dental wire)
• Implanted cardiac pacemaker or neurostimulator
• Somatic symptom and related disorders
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56869.091.16 |