The aim of this study is to demonstrate that accurate brain stimulation is possible in anatomical location and timing.
ID
Source
Brief title
Condition
- Cranial nerve disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the phase difference (error) between the estimated
phase of EEG activity and the phase of the delivered stimulation at the target
location.
Secondary outcome
Phase change in the brain waves (10 Hz alpha activity) due to different tCS
modalities and stimulation parameters used
Amplitude change in the brain waves (10 Hz alpha activity) due to different tCS
modalities and stimulation parameters used
Background summary
Transcranial current stimulation (tCS) is a method in which small currents are
applied to different places on the scalp to change the activity of specific
brain regions. tCS has been extensively studied for its potential to stimulate
brain regions in an accessible, non-invasive and pain-free manner. Potential
applications include the treatment of psychiatric or neurological disorders.
Brain activity is characterized by rapid changes. These rapid changes affect
the response to tCS and its subsequent effects. It is therefore necessary to
consider the timing of the stimulation during tCS, as this provides better
control of the tCS effects and helps to better understand these effects. This
can be achieved with the so-called "close-loop tCS" approach, where the applied
current is changed based on the measured brain activity.
However, current methods for closed-loop tCS suffer from artefacts in the
measurements caused by the stimulation itself. Also, some methods estimate
brain activity based on predictive models and thus do not rely on the actual
measured signals. In both cases, the stimulation is less effective.
This study proposes a novel closed-loop tCS setup that could overcome these
drawbacks. The aim of this study is to demonstrate that accurate brain
stimulation is technically possible in space and timing.
In the long term, the current study could contribute to increasing the
knowledge about the effects of non-invasive tCS on brain activity and thereby
improving tCS treatments.
Study objective
The aim of this study is to demonstrate that accurate brain stimulation is
possible in anatomical location and timing.
Study design
Interventional, open label. All participants receive the same interventions.
Intervention
During this study, 3 different types of commonly used stimulation patterns are
applied in random order. Each stimulation pattern with a different set of
parameters where the amplitude and periodicity of the current delivered varies
(9 combinations are tested per stimulation type).
For each stimulation type, the steps described below are repeated 5 times:
Stimulation type 1 (15 minutes)
5 seconds recording of brain activity without stimulation (25 seconds in
total)
5 seconds of brain stimulation (25 seconds in total)
10 minutes rest
Repositioning the Electrodes for Type 2 Stimulation (1 minute)
Stimulation type 2 (15 minutes)
5 seconds recording of brain activity without stimulation (25 seconds in
total)
5 seconds of brain stimulation (25 seconds in total)
10 minutes rest
Repositioning the electrodes for type 3 stimulation (1 minute)
Stimulation type 3 (15 minutes)
5 seconds recording of brain activity without stimulation (25 seconds in
total)
5 seconds of brain stimulation (25 seconds in total)
Study burden and risks
The main burden consists of the time that subjects lose to participate,
approximately 1.45 hours.
Like TMS, tCS is considered safe and well tolerated.
However, it can cause some side effects:
Headache
Scalp discomfort at the site of stimulation
Tingling, spasm or twitching of the facial muscles
Dizziness
Other possible side effects are related to increased skin sensitivity or
redness around the areas where the electrodes are placed on the scalp.
High tech campus 31
Eindhoven 5654AE
NL
High tech campus 31
Eindhoven 5654AE
NL
Listed location countries
Age
Inclusion criteria
Signed informed consent
Age between 18 and 64
Exclusion criteria
- Wounded or particular sensitive skin at areas of investigation. For example,
skin-rash, discoloration, scars, or open wounds
- Allergies to adhesive or dry electrodes or silver chloride
- Pregnant or lactating
- Any of the following symptoms: fever, tiredness, dry cough, aches and pains,
nasal congestion, runny nose, sore -throat, diarrhea.
- Known neurological disorders
- Previous epileptic episodes
- Active implants, such as pacemakers or brain stimulators
- Intracranial metal implants
- IMEC employees
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 | NL82733.015.22 |
| Other | Studie wordt geregistreerd op www.clinicaltrials.gov voor eerste inclusie |