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Improving cognitive performance in MS by transcranial alternating current brain stimulation (tACS); a pilot study


- candidate number27183
- NTR NumberNTR6428
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-mei-2017
- Secondary IDsUMCG Research Register: 201700089 ABR number 60761
- Public TitleImproving cognitive performance in MS by transcranial alternating current brain stimulation (tACS); a pilot study
- Scientific TitleImproving cognitive performance in MS by transcranial alternating current brain stimulation (tACS); a pilot study
- ACRONYMtACS in MS
- hypothesisWe hypothesize that tACS can enhance brain synchronization between frontal and parietal regions, thereby improving cognitive functioning in MS patients.
- Healt Condition(s) or Problem(s) studiedMultiple sclerosis (MS)
- Inclusion criteria- MS patients with subjective complaints of cognitive impairment or on the recommendation of attending neurologist;
- age 30-60 years;
- MRI compatible;
- 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.
- Diagnosis of MS according to the 2010 McDonald criteria;
- No relapse in the last 3 months before the test;
- Signed written informed consent;
- Right handedness.
- Exclusion criteria1. History of psychiatric or neurological illness other than MS
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 Tetrahydrocannabinol (THC) or any other nonprescription psychopharmaca;
11. Refusal to be informed of structural brain abnormalities that could be detected using MRI during the experiment
12. Diagnosis of epilepsy, or a personal or first degree family history of epileptic seizures, diagnosis of Parkinson’s disease, Myasthenia Gravis, epilepsy and dementia
13. Severe scalp skin lesions
14. Color blindness
Participants are asked not to use alcohol, THC and other above mentioned medication during the course of the study.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- TypeSingle arm
- Studytype[default]
- planned startdate 1-mei-2017
- planned closingdate1-jun-2018
- Target number of participants0
- InterventionsTranscranial alternating current stimulation (tACS) in theta range (6 Hz) applied over frontal and parietal regions synchronously
- Primary outcome1. Trial endpoints in coherence of EEG signal in theta range
2. Difference in reaction times on Vienna Reaction Time task.
- Secondary outcome1. baseline measures of cognitive performance and lesion load estimated from DTI and MTR measurements as predictors/covariates.
2.post - vs pre –stimulation Neuropsychological evaluation (NPE) scores
- TimepointsParticipants recruitment immediately after METC approved;
2. Measurements finalized as soon as enough participants are found;
3. Primary and secondary outcomes up to 6 months after the data were collected for the last subject.
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES B Curcic
- CONTACT for SCIENTIFIC QUERIES B Curcic
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Dutch MS Research Foundation
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD9-mei-2017 - 10-jul-2017


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