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
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
Alzheimer's disease
(BASEC)
Kriterien zur Teilnahme
• 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)
Ausschlusskriterien
• 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)
Ausschlusskriterien
• 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)
Studienstandort
Genf
(BASEC)
Switzerland (ICTRP)
Sponsor
Lucie Bréchet, PhD
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Lucie Bréchet, PhD
+41 (0) 22 379 08 52
lucie.brechet@clutterunige.chUniversity of Geneva
(BASEC)
Allgemeine Auskünfte
(ICTRP)
Wissenschaftliche Auskünfte
Geneva University Hospitals (HUG)
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Genf
(BASEC)
Datum der Bewilligung durch die Ethikkommission
02.02.2022
(BASEC)
ICTRP Studien-ID
NCT05708001 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
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)
Öffentlicher Titel
Improvement of Memory in Mild Cognitive Impairment (ICTRP)
Untersuchte Krankheit(en)
Mild Cognitive Impairment
(ICTRP)
Untersuchte Intervention
Diagnostic Test: Montreal Cognitive Assessment (MoCA)
Device: high-density electroencephalography (hdEEG)
Device: transcranial alternating current stimulation (tACS)
(ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
cognitive status measured by Montreal Cognitive Assessment (MoCA)
(ICTRP)
modulation of gamma activity assessed with high-density EEG
(ICTRP)
Registrierungsdatum
12.01.2023 (ICTRP)
Einschluss des ersten Teilnehmers
01.02.2023 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Lucie Bréchet, PhD (ICTRP)
Sekundäre IDs
2021-D0055 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05708001 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar