HumRes63559
|
SNCTP000004788
|
BASEC2021-D0055
|
NCT05708001
Improvement of memory for mild cognitive impairment with transcranial alternating current stimulation (tACS) performed by EEG and MRI: A randomized, two parallel group, double-blind study
Descrizione riassuntiva dello studio
The proposed study will systematically examine the feasibility and efficacy of tACS for elderly individuals with memory loss. This study will provide data to support the safety and efficacy of tACS. tACS will be applied repeatedly at home in this population. This may lead to future research to introduce tACS in the prevention and treatment of memory loss in elderly individuals who do not have the time to travel to a clinic due to disability or who live too far away.
(BASEC)
Intervento studiato
The study is randomized, controlled, with two parallel groups and double-blind. It includes 12 weeks of daily stimulation sessions at home. Participants with mild cognitive impairment (MCI) are randomly assigned to an active/real group or placebo/control group. We will measure the change in memory scores between baseline and follow-up at 1 and 3 months. Memory values are measured with various questionnaires and neuropsychological tasks.
(BASEC)
Malattie studiate
Alzheimer's disease
(BASEC)
Criteri di partecipazione
• Age ≥55 years • Clinical diagnosis of mild cognitive impairment (MCI) through the Memory Center, HUG procedure • Confirmation of the diagnosis by the study physician based on a holistic view of the cognitive assessment and the participant's history • Understanding of the information and consent statement • Able and willing to meet all study requirements • The consent statement has been signed (BASEC)
Criteri di esclusione
• Age <55 years • any current diagnosis of a psychiatric disorder (e.g., schizophrenia, bipolar disorder, depressive disorder) • Except for MCI, any history of any other progressive or genetic neurological disease (e.g., Parkinson's disease, multiple sclerosis, tuberous sclerosis) or acquired neurological disease (e.g., stroke, traumatic brain injury, tumor), including intracranial lesions • History of traumatic brain injury resulting in persistent loss of consciousness • Recent history of poorly controlled headaches, including chronic medications for migraine prevention • History of fainting of unknown or indeterminate etiology that may represent seizures • History of seizures, diagnosis of epilepsy • Any unstable or uncontrolled chronic medical condition that, in the event of a provoked seizure, may lead to a medical emergency (heart defect, cardiac arrhythmia, asthma, etc.) • Contraindication for an MRI or the use of tACS • Any metallic body in the brain or skull (except dental fillings) or elsewhere in the body, unless approved by the responsible treating physician (e.g., MRI-compatible joint replacement) • Any device such as a pacemaker, drug pump, nerve stimulator, unless approved by the responsible treating physician (BASEC)
• Age ≥55 years • Clinical diagnosis of mild cognitive impairment (MCI) through the Memory Center, HUG procedure • Confirmation of the diagnosis by the study physician based on a holistic view of the cognitive assessment and the participant's history • Understanding of the information and consent statement • Able and willing to meet all study requirements • The consent statement has been signed (BASEC)
Criteri di esclusione
• Age <55 years • any current diagnosis of a psychiatric disorder (e.g., schizophrenia, bipolar disorder, depressive disorder) • Except for MCI, any history of any other progressive or genetic neurological disease (e.g., Parkinson's disease, multiple sclerosis, tuberous sclerosis) or acquired neurological disease (e.g., stroke, traumatic brain injury, tumor), including intracranial lesions • History of traumatic brain injury resulting in persistent loss of consciousness • Recent history of poorly controlled headaches, including chronic medications for migraine prevention • History of fainting of unknown or indeterminate etiology that may represent seizures • History of seizures, diagnosis of epilepsy • Any unstable or uncontrolled chronic medical condition that, in the event of a provoked seizure, may lead to a medical emergency (heart defect, cardiac arrhythmia, asthma, etc.) • Contraindication for an MRI or the use of tACS • Any metallic body in the brain or skull (except dental fillings) or elsewhere in the body, unless approved by the responsible treating physician (e.g., MRI-compatible joint replacement) • Any device such as a pacemaker, drug pump, nerve stimulator, unless approved by the responsible treating physician (BASEC)
Luogo dello studio
Ginevra
(BASEC)
Switzerland (ICTRP)
Sponsor
Lucie Bréchet, PhD
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Lucie Bréchet, PhD
+41 (0) 22 379 08 52
lucie.brechet@clutterunige.chUniversity of Geneva
(BASEC)
Informazioni generali
(ICTRP)
Informazioni scientifiche
Geneva University Hospitals (HUG)
(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ginevra
(BASEC)
Data di approvazione del comitato etico
02.02.2022
(BASEC)
ID di studio ICTRP
NCT05708001 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Improvement of memory in Mild Cognitive Impairment (MCI) using transcranial alternating current stimulation (tACS) guided by EEG and MRI: a randomized, sham-controlled, parallel-arm, double-blind study (BASEC)
Titolo accademico
Improvement of Memory in Mild Cognitive Impairment (MCI) Using Transcranial Alternating Current Stimulation (tACS) Guided by EEG and MRI: a Randomized, Sham-controlled, Parallel-arm, Double-blind Study (ICTRP)
Titolo pubblico
Improvement of Memory in Mild Cognitive Impairment (ICTRP)
Malattie studiate
Mild Cognitive Impairment
(ICTRP)
Intervento studiato
Diagnostic Test: Montreal Cognitive Assessment (MoCA)
Device: high-density electroencephalography (hdEEG)
Device: transcranial alternating current stimulation (tACS)
(ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
Mild Cognitive Impairment (MCI) patients
- age = 55 years old
- clinical diagnosis of mild cognitive impairment (MCI) based on a comprehensive
clinical assessment and standard neuropsychological examination including tests of
language, visuospatial thinking, executive functions, and memory
- confirmation of diagnosis will be made by Prof. Giovanni Frisoni, the study MD, based
on a participant's cognitive evaluation and history
- understanding of the informed consent
- able and willing to comply with all study requirements
- informed consent form was signed
- women of childbearing potential (WOCBP) must perform a pregnancy test during screening
Caregiver
- minimum 21 years of age
- self-reported computer/tablet proficiency
- willingness to learn how to use tACS
- availability during the study period to administer tACS to the participant
- informed consent form was signed
- women of childbearing potential (WOCBP) must perform a pregnancy test during screening
Exclusion Criteria:
Mild Cognitive Impairment (MCI) patients
- age < 55 years old
- any current diagnosis of a psychiatric disorder (e.g., schizophrenia, bipolar
disorder, depressive disorder)
- other than MCI, any history of other progressive or genetic neurologic disorder (e.g.,
Parkinson's disease, multiple sclerosis, tubular sclerosis) or acquired neurological
disease (e.g., stroke, traumatic brain injury, tumor), including intracranial lesions
- history of head trauma resulting in prolonged loss of consciousness
- current history of poorly controlled headaches including chronic medication for
migraine prevention
- history of fainting spells of unknown or undetermined etiology that might constitute
seizures
- history of seizures, diagnosis of epilepsy
- any unstable medical condition or chronic uncontrolled medical conditions that may
cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac
dysrhythmia, asthma, etc.)
- contraindication for undergoing MRI or receiving tACS
- any metal in the brain or skull (excluding dental fillings) or elsewhere in the body
unless cleared by the responsible covering MD (e.g., MRI compatible joint replacement)
- any skin problems, such as dermatitis, psoriasis, or eczema
- any electrically, magnetically, or mechanically activated implanted devices such as a
pacemaker, intracranial electrodes, implanted defibrillators, medication pumps, nerve
stimulators, vascular clips, or any other prosthesis in the brain
- any serious life-threatening disease such as congestive heart failure, pulmonary
obstructive chronic disease, or active neoplasia
- pregnant women
- adults lacking capacity for consent
Caregiver
- insufficient understanding of study procedures
- poor eyesight, severe arthritis in the hands, pain, deformity or other condition that
interferes with successful administration of tACS
(ICTRP)
non disponibile
Endpoint primari e secondari
cognitive status measured by Montreal Cognitive Assessment (MoCA)
(ICTRP)
modulation of gamma activity assessed with high-density EEG
(ICTRP)
Data di registrazione
12.01.2023 (ICTRP)
Inclusione del primo partecipante
01.02.2023 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
Lucie Bréchet, PhD (ICTRP)
ID secondari
2021-D0055 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05708001 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile