Transiently improve episodic memory in early AD patients with precuneal gamma (40 Hz) tACS (main objective) and identify what functional brain activity/network changes underlie this memory improvement (secondary objective)
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
neurodegeneratieve aandoeningen, dementie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in episodic memory task score (Rey Auditory Verbal Learning test total
and long delayed recall score (a) and Face-Name Association Task score (b))
from before to after tACS
Secondary outcome
Canges in brain (network) activity from before to after tACS
Background summary
The 32 million Alzheimer*s disease (AD) and 69 million prodromal AD patients
worldwide contribute to a large economic burden. Effective and safe therapies
that slow or prevent the progression from mild cognitive impairment (MCI) to AD
are therefore of high priority. Transcranial alternating current stimulation
(tACS) is a safe and patient-friendly non-invasive brain stimulation technique
that serves as a potential candidate for reducing and/or slowing cognitive
impairment. Application of tACS in the gamma frequency range, specifically
around 40 Hz, has been studied in patients with AD and MCI due to AD. In these
patients, a single session of 40 Hz tACS at the precuneus showed to improve
episodic memory, and to increase gamma power, as measured with
electroencephalography. These findings will be replicated in the current study
in patients with MCI due to AD, using magnetoencephalography (MEG) recorded
before, during and after tACS. In this way, brain activity and network changes
that underlie this improvement in episodic memory can be studied with greater
temporal and spatial detail.
Study objective
Transiently improve episodic memory in early AD patients with precuneal gamma
(40 Hz) tACS (main objective) and identify what functional brain
activity/network changes underlie this memory improvement (secondary objective)
Study design
A double-blind, randomized, sham-controlled, cross-over trial with concurrent
tACS-MEG
Intervention
Gamma (40 Hz) and sham tACS at the precuneus region for 48 minutes
Study burden and risks
Skin irritation and a tingling of slight burning/itching sensation on the scalp
at the start and end of stimulation as common side effects of tACS. These side
effects are transient and actions are taken to minimize their occurrence as
much as possible. The risk of inducing an epileptic seizure remains negligible.
Transient improvements in episodic memory and underlying brain network activity
are expected in the participants after active stimulation. Importantly, more
knowledge about the working mechanisms of the cognitive deficits in early AD
and possible treatment options is obtained by this study. Thus, the potential
benefits outweigh the negligible risks.
De Boelelaan 1117
Amsterdam 1081 HZ
NL
De Boelelaan 1117
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
Recent (not more than 6 months ago) amnestic mild cognitive impairment
diagnosis, corroborated by abnormal ratio of phosporylated tau and
beta-amyloid-42 ratio (of >0.023).
Additionally, a signed informed consent for the Amsterdam Dementia Cohort
(P2016.061) is required.
Exclusion criteria
Suffering from serious neurological, psychiatric or somatic comorbidity.
Suffering from epileptic seizures or severe claustrophobia.
Intensive use of psychoactive medication.
Having a cardiac pacemaker, internal cardiac defibrillator or other
intracorporeal device that interferes with MEG-recordings.
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 |
|---|---|
| ClinicalTrials.gov | NCT06202872 |
| CCMO | NL85863.018.23 |