Here we will test the hypothesis that tACS (theta-tACS at 6 Hz) will enhance brain synchrony in MS patients, thereby improving their cognitive functioning. We further want to achieve the increase in fronto-temporal brain synchronization measured by…
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Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The changes in EEG coherence and in speed of information processing in patients
with MS using tACS.
EEG coherence will be estimated between frontal and parietal regions from RS
EEG recordings. The information processing speed will be measured using the
Vienna Reaction Time Task (VRTT).
Secondary outcome
n.a.
Background summary
Mild to severe cognitive impairment in MS is widespread (45-70 %) and highly
detrimental to quality of life. Minimizing cognitive decline, which is due to
the deterioration of brain connections involved in cognitive processing, will
thus be of great benefit. Current treatment does not target affected brain
connections directly and involves long and intensive cognitive training in the
clinic, presenting a heavy burden to patients. Therefore, an alternative
treatment that would speed up or replace the cognitive training would decrease
the load on patients and make treatment more feasible.
Transcranial alternating current stimulation (tACS) is a novel treatment
modality that directly influences brain oscillations and thereby increases
cognitive performance and speed of processing in healthy volunteers. tACS
application and safety procedures are the same as the transcranial direct
current stimulation (tDCS) that is already used in clinical trials of
psychiatric patients within our group at the UMCG. tACS has also been
successfully applied in neurological patients (e.g. Mild Cognitive impairment
and Alzheimer*s disease). Furthermore, tACS can be delivered in patients*
homes, and potentially by remotely controlled self-treatment. tACS has not yet
been investigated in MS patients, likely since it is relatively novel (<10
years) and requires knowledge of brain oscillations and connectivity. Due to
brain lesions in MS patients, the question is if tACS can deliver any effect in
these patients.
Study objective
Here we will test the hypothesis that tACS (theta-tACS at 6 Hz) will enhance
brain synchrony in MS patients, thereby improving their cognitive functioning.
We further want to achieve the increase in fronto-temporal brain
synchronization measured by EEG induced by the tACS.
Study design
Participants in the study will be randomly assigned to one of the two groups.
One group will receive real brain stimulation (tACS) and the second group will
receive sham stimulation (sham tDCS). Before brain stimulation, participants
will undergo an EEG and MRI scanning session. EEG will be recorded for 10
minutes: patients will rest with their eyes open. During MRI, we will collect
various anatomical brain measures such as anatomical MRI, Diffusion tensor
imaging (DTI), magnetic transfer ration (MTR) and functional resting state
(RS). Prior to the stimulation, participants will also fill in a few
questionnaires and perform cognitive tests. During tACS patients will perform a
cognitive task that enhances the effect of stimulation. The stimulation will be
repeated for 3 consecutive days. After the last tACS session, patients will
repeat the EEG RS recording and cognitive tests.
Healthy controls will undergo 1 MRI scan, 2 EEG recordings, 1 NPE and VRTT, and
1 tACS session. Resting state EEG will be measured immediately before and after
the tACS.
Study burden and risks
Participants in the study will go through 5 steps that will take place across
five or six consecutive days. The initial step will be NPE testing (60
minutes). If the patients fulfill CI criteria, she/he will undergo the second
step a pre-stimulation EEG measurement and an MRI scanning session. The EEG
session will last 10 minutes (including twenty minutes preparation time, total
30 minutes). The MRI session will last for ~ 40 minutes. After the MRI,
participants will fill perform cognitive Vienna reaction time task. This takes
14 minutes. On the third and the fourth day, participants will undergo brain
stimulation (tACS or sham tDCS). The stimulation session will last 25 minutes
(preparation: 10 minutes, stimulation: 15 minutes). On the 5th day,
participants will undergo the brain stimulation followed by brief EEG
recording, VRTT and NPE. If patients express that the second step or the final
step last too long, we might split it in two days, or for example couple the
pre-stimulation EEG session with the first day of stimulation. This will be
adjusted solely to decrease the burden to patients as much as possible. It is
important to measure the post-stimulation EEG and the VRTT immediately after
the last stimulation thus the final tACS has to be coupled with the
post-stimulation VRTT and EEG.
The experiment will not involve more than minimal risks for the
participants. MRI is a standard brain imaging technique with no known negative
effects on health. The only risks are for subjects with cardiac pacemaker and
metal implants. These individuals will not be allowed to participate. In terms
of burden, MRI involves lying still in a confined environment during one hour.
In addition, during data acquisition, the MRI scanner makes a loud noise, and
although participants are provided with earplugs, the residual noise can be a
burden for some individuals.
During the tACS procedure participants are exposed to a very low electrical
current of 2 mA. The use of tACS to date has not resulted in adverse effects,
apart from mild headache or a mild tingling sensation underneath the
electrodes. Finally, EEG involves a measurement of brain currents and is not
associated with any contraindication.
Healthy participants will undergo 1 MRI and 2 EEG sessions, 1 NPE and VRTT, and
1 tACS session.
Antonius Deusinglaan 2 Ant. Deusinglaan 2
Groningen 9713 AW
NL
Antonius Deusinglaan 2 Ant. Deusinglaan 2
Groningen 9713 AW
NL
Listed location countries
Age
Inclusion criteria
MS Patients:
Diagnosis of MS according to the MacDonald criteria
Age: 30 - 60 years
Cognitive impairment (CI): CI patients will have decreased values (1.5 standard
deviations below the normative control values or below cut-off value for
deviation) on at least 2 tests from NPE battery.
Signed written informed consent and right handedness.
Healthy participants:
Age: 30 - 60 years
Signed written informed consent and right handedness.
Exclusion criteria
1. History of psychiatric or neurological illness other than MS for MS patients
or History of psychiatric or neurological illness for healthy participants
2. Metal implants (e.g., pacemaker, heart valves, vascular clips, eye-implants,
copper containing intra-uterine devices, non-removable piercing, cerebral
implants)
3. Any risk of having metal particles in the eyes
4. Tattoos containing iron oxide (often found in red pigments)
5. (Suspected) Pregnancy or breast feeding
6. Claustrophobia
7. Alcohol or drug abuse
8. Excessive intake of coffee (>5 units per day) or alcohol (>2 units per day);
9. Recent use of alcohol (2 days before the EEG and/or fMRI measurement).
10. Recent use (within one week) of cannabis, benzodiazepine, baclofen or any
other nonprescription psychopharmaca;
11. Refusal to be informed of structural brain abnormalities that could be
detected during the experiment
12. Diagnosis of epilepsy, Parkinson*s disease, Myasthenia Gravis, epilepsy and
dementia.
13. Severe scalp skin lesions
14. Color blindness
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 | NL60761.042.17 |