xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05999916</url>
    </required_header>
    <id_info>
      <org_study_id>BTN-100</org_study_id>
      <nct_id>NCT05999916</nct_id>
    </id_info>
    <brief_title>Evaluate the Safety and Feasibility of tACS With the Miamind Neurostimulator in Healthy Participants</brief_title>
    <acronym>MindStim</acronym>
    <official_title>A Prospective, Single-Arm, Monocentric Pilot Study to Evaluate the Safety and Feasibility of Transcranial Alternate Current Stimulation With the Miamind Neurostimulator in Healthy Participants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bottneuro AG</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Hemex AG</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Bottneuro AG</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The present study aims to assess the safety and feasibility of repeated transcranial&#xD;
        alternating current stimulation (tACS) by the Miamind Neurostimulator in a cohort of healthy&#xD;
        participants. Based on the findings of this investigation, subsequent clinical trials&#xD;
        assessing the efficiency of tACS by the Miamind Neurostimulator for treatment of Alzheimer's&#xD;
        Disease will be conducted.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The pathological hallmarks of Alzheimer's Disease (AD) are extracellular amyloid-β (Aβ)&#xD;
        plaques and intracellular neurofibrillary tangles of hyperphosphorylated tau deposition in&#xD;
        the brain together with neuroinflammation and microglial activation. These alterations lead&#xD;
        to synaptic dysfunction, neuronal loss, and subsequently to brain circuit and brain&#xD;
        oscillation disruption, resulting in cognitive decline. Recent studies have shown a positive&#xD;
        effect of neural entrainment at gamma frequency (30-80 Hz). Transcranial alternating current&#xD;
        stimulation (tACS) utilizes low amplitude alternating currents, allowing for frequency and&#xD;
        region-specific brain oscillation entrainment showing positive results regarding improvement&#xD;
        of cognitive functions in healthy participants and Alzheimer's Disease patients. Miamind&#xD;
        Neurostimulator is a patient specific MRI-based 3D printed medical device that permits&#xD;
        electrical stimulation and recording on up to 32 electrode channels and thus allows for&#xD;
        simultaneous, multifocal, and targeted brain stimulation. tACS is non- invasive, well&#xD;
        tolerated by users and considered safe with no persistent adverse events reported.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 6, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>The present study aims to assess the safety and feasibility of employing repeated (4 sessions at 4 days) transcranial alternating current stimulation (tACS) through the utilization of the Miamind Neurostimulator in a cohort of healthy participants.</intervention_model_description>
      <primary_purpose>Device Feasibility</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety: Incidence of Treatment-Emergent Adverse Events</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>Safety of the Treatment defined as the proportion of study participants free of serious adverse device effects and unanticipated serious adverse device effects (SADE and USADE) assessed via a safety questionnaire and medical evaluation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Safety and comfort: questionnaire</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>Adverse Events and comfort of tACS and the medical device are reported by questionnaires following stimulation of each target region at visit °3 &amp; °4 and following sequential stimulation of multiple target regions at visit °5 &amp; °6.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of functional impact of tACS on Attention and Concentration: d2-R attention test</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>Changes in d2-R attention test are reported to document the functional impact of tACS on concentration and attention before and after stimulation of each target region at visit °3 &amp; °4 and before and after sequential stimulation of multiple target regions at visit °5 &amp; °6.&#xD;
  The d2-R attention test measures processing speed, rule compliance, and quality of performance as estimation of attention and concentration and scores them as the following separate items: speed, concentration, carefulness. Each item is scored from 20-80. A higher score indicates better performance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of functional impact of tACS on oscillatory activity: Electroencephalography (EEG)</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>Quantification of EEG measurements to document the functional impact of tACS on oscillatory activity in individual frequency bands (delta, theta, alpha, beta, gamma) and EEG-biomarkers (alpha peak frequency, Vigilance) before and after stimulation of each target region at visit °3 &amp; °4 &amp; °5 &amp; °6.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive Evaluation: Montreal Cognitive Assessment (MoCA)</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>MoCA scores are documented before and after visit °3 and after visit °6 to evaluate the impact of repeated tACS on cognitive performance.&#xD;
  The MoCA has a total scoring range of 0-30, with the score based on the number of correct answers made in each of the 7 following items: Visuospatial/Executive, Naming, Memory/delayed recall, Attention, Language, Abstraction, Orientation. Sub-scores and total score are reported.&#xD;
  A lower total score indicate greater cognitive impairment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant coherence and satisfaction questionnaire</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>The subjective impression and satisfaction of the participant regarding the device and the intervention is documented using a one-time questionnaire at the end of the study.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">8</enrollment>
    <condition>Healthy Participants</condition>
    <condition>Healthy Population</condition>
    <arm_group>
      <arm_group_label>60 min session of 40Hz tACS by Miamind Neurostimulator</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The clinical study will enroll eight (8) participants who will undergo four (4) tACS sessions (one per day) within 4 consecutive days. The tACS intervention will last 60 min in total. The stimulation frequency will be 40 Hz with max 1 mA/electrode and total of max 2 mA across all active electrodes (peak-to-baseline).</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Personalized Miamind Neurostimulator</intervention_name>
      <description>60 min. 40 Hz max. 1mA / electrode &amp; total of max. 2 mA across all electrodes. 30- s ramp-up personalised intervention based on individual modelling of electric field distribution to maximise therapeutic effect in the target region. Three target regions, consecutively stimulated (20min each).</description>
      <arm_group_label>60 min session of 40Hz tACS by Miamind Neurostimulator</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Participants who are overtly healthy as determined by medical evaluation including&#xD;
               medical history and physical examination.&#xD;
  &#xD;
            2. Able and willing to provide voluntary written Informed Consent and sign the ICF to&#xD;
               participate in the study prior to any study-related procedure.&#xD;
  &#xD;
            3. Must have the ability to comply with protocol-related tests, appointments, and&#xD;
               procedures.&#xD;
  &#xD;
            4. Age over 18 years old.&#xD;
  &#xD;
            5. Knowledge of the German language (B1 or higher).&#xD;
  &#xD;
            6. No history of intellectual or learning disability; at least 8 grades of school.&#xD;
  &#xD;
            7. Non-disturbing hairstyle or headdress that enables electrode contact with the scalp&#xD;
               judged by the investigator.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any acute or chronic disease/disorder (e.g., cerebral, psychiatric, cardiovascular,&#xD;
               pulmonary, metabolic, skin etc.)&#xD;
  &#xD;
            2. History of traumatic brain injury or other diseases of the central nervous system.&#xD;
  &#xD;
            3. History of seizures, diagnosis of epilepsy, or abnormal (epileptiform) EEG, or&#xD;
               immediate (1st-degree relative) family history of epilepsy.&#xD;
  &#xD;
            4. Diagnosis of substance abuse.&#xD;
  &#xD;
            5. Participant is under the influence of alcohol, and consumption of narcotics or&#xD;
               benzodiazepines, or other sleeping medications prior to the procedure.&#xD;
  &#xD;
            6. All female participants that are not post-menopausal (defined as at least 12 months of&#xD;
               spontaneous amenorrhea in women over 45 years old) or surgically sterile (e.g.&#xD;
               bilateral tubal ligation, hysterectomy, bilateral oophorectomy) will be required to&#xD;
               have a pregnancy test; any participant who is pregnant or breastfeeding will not be&#xD;
               enrolled in the study.&#xD;
  &#xD;
            7. Metal implants (excluding dental fillings) or devices such as a pacemaker,&#xD;
               cardioverter defibrillator, medication pump, nerve stimulator, Transcutaneous&#xD;
               Electrical Nerve Stimulator (TENS) unit, ventriculoperitoneal shunt, and cochlear&#xD;
               implant, unless cleared by the study MD.&#xD;
  &#xD;
            8. Contraindications for undergoing MRI.&#xD;
  &#xD;
            9. Ongoing participation in any other interventional clinical study with an&#xD;
               investigational drug or another MD within the 30 days preceding and during the present&#xD;
               investigation.&#xD;
  &#xD;
           10. Participants not suitable for the study based on a holistic consideration of the&#xD;
               participant's history and the PI's medical expertise.&#xD;
  &#xD;
          No vulnerable subject is enrolled on this study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alois Hopf, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Bottneuro AG</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alois Hopf, PhD</last_name>
      <phone>+41 61 515 00 43</phone>
      <email>alois.hopf@bottneuro.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Bekim Osmani, PhD</last_name>
      <phone>+41 61 515 00 43</phone>
      <email>bekim.osmani@bottneuro.ch</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Universitätsspital Basel</name>
        <address>
          <city>Basel</city>
          <state>Basel-Stadt</state>
          <zip>4031</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <contact>
        <last_name>Raphael Guzman, Prof</last_name>
        <phone>+41 61 704 13 30</phone>
      </contact>
      <contact_backup>
        <last_name>Birsel Klein-Reesink</last_name>
        <phone>+41 61 265 71 24</phone>
        <email>birsel.klein-reesink@usb.ch</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <link>
      <url>http://bottneuro.ch/en</url>
      <description>Bottneuro Website</description>
    </link>
    <reference>
      <citation>Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.</citation>
      <PMID>28709880</PMID>
    </reference>
    <reference>
      <citation>Nissim NR, McAfee DC, Edwards S, Prato A, Lin JX, Lu Z, Coslett HB, Hamilton RH. Efficacy of Transcranial Alternating Current Stimulation in the Enhancement of Working Memory Performance in Healthy Adults: A Systematic Meta-Analysis. Neuromodulation. 2023 Jun;26(4):728-737. doi: 10.1016/j.neurom.2022.12.014. Epub 2023 Feb 8.</citation>
      <PMID>36759231</PMID>
    </reference>
    <reference>
      <citation>Menardi A, Rossi S, Koch G, Hampel H, Vergallo A, Nitsche MA, Stern Y, Borroni B, Cappa SF, Cotelli M, Ruffini G, El-Fakhri G, Rossini PM, Dickerson B, Antal A, Babiloni C, Lefaucheur JP, Dubois B, Deco G, Ziemann U, Pascual-Leone A, Santarnecchi E. Toward noninvasive brain stimulation 2.0 in Alzheimer's disease. Ageing Res Rev. 2022 Mar;75:101555. doi: 10.1016/j.arr.2021.101555. Epub 2021 Dec 30.</citation>
      <PMID>34973457</PMID>
    </reference>
    <reference>
      <citation>Benussi A, Cantoni V, Grassi M, Brechet L, Michel CM, Datta A, Thomas C, Gazzina S, Cotelli MS, Bianchi M, Premi E, Gadola Y, Cotelli M, Pengo M, Perrone F, Scolaro M, Archetti S, Solje E, Padovani A, Pascual-Leone A, Borroni B. Increasing Brain Gamma Activity Improves Episodic Memory and Restores Cholinergic Dysfunction in Alzheimer's Disease. Ann Neurol. 2022 Aug;92(2):322-334. doi: 10.1002/ana.26411. Epub 2022 Jun 6.</citation>
      <PMID>35607946</PMID>
    </reference>
    <reference>
      <citation>Dhaynaut M, Sprugnoli G, Cappon D, Macone J, Sanchez JS, Normandin MD, Guehl NJ, Koch G, Paciorek R, Connor A, Press D, Johnson K, Pascual-Leone A, El Fakhri G, Santarnecchi E. Impact of 40 Hz Transcranial Alternating Current Stimulation on Cerebral Tau Burden in Patients with Alzheimer's Disease: A Case Series. J Alzheimers Dis. 2022;85(4):1667-1676. doi: 10.3233/JAD-215072.</citation>
      <PMID>34958021</PMID>
    </reference>
    <reference>
      <citation>Sprugnoli G, Munsch F, Cappon D, Paciorek R, Macone J, Connor A, El Fakhri G, Salvador R, Ruffini G, Donohoe K, Shafi MM, Press D, Alsop DC, Pascual Leone A, Santarnecchi E. Impact of multisession 40Hz tACS on hippocampal perfusion in patients with Alzheimer's disease. Alzheimers Res Ther. 2021 Dec 20;13(1):203. doi: 10.1186/s13195-021-00922-4.</citation>
      <PMID>34930421</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Alzheimer Disease</keyword>
    <keyword>tACS</keyword>
    <keyword>Memory Problems</keyword>
    <keyword>Cognitive Impairment</keyword>
    <keyword>Cognitive Performance</keyword>
    <keyword>Safety and Tolerability</keyword>
    <keyword>Feasibility</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05999916
  org study id: BTN-100
  nct id: NCT05999916
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The present study aims to assess the safety and feasibility of repeated transcranial
        alternating current stimulation (tACS) by the Miamind Neurostimulator in a cohort of healthy
        participants. Based on the findings of this investigation, subsequent clinical trials
        assessing the efficiency of tACS by the Miamind Neurostimulator for treatment of Alzheimer's
        Disease will be conducted.
  The pathological hallmarks of Alzheimer's Disease (AD) are extracellular amyloid-β (Aβ)
        plaques and intracellular neurofibrillary tangles of hyperphosphorylated tau deposition in
        the brain together with neuroinflammation and microglial activation. These alterations lead
        to synaptic dysfunction, neuronal loss, and subsequently to brain circuit and brain
        oscillation disruption, resulting in cognitive decline. Recent studies have shown a positive
        effect of neural entrainment at gamma frequency (30-80 Hz). Transcranial alternating current
        stimulation (tACS) utilizes low amplitude alternating currents, allowing for frequency and
        region-specific brain oscillation entrainment showing positive results regarding improvement
        of cognitive functions in healthy participants and Alzheimer's Disease patients. Miamind
        Neurostimulator is a patient specific MRI-based 3D printed medical device that permits
        electrical stimulation and recording on up to 32 electrode channels and thus allows for
        simultaneous, multifocal, and targeted brain stimulation. tACS is non- invasive, well
        tolerated by users and considered safe with no persistent adverse events reported.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: The present study aims to assess the safety and feasibility of employing repeated (4 sessions at 4 days) transcranial alternating current stimulation (tACS) through the utilization of the Miamind Neurostimulator in a cohort of healthy participants.
  primary purpose: Device Feasibility
  masking: None (Open Label)
  measure: Safety: Incidence of Treatment-Emergent Adverse Events
  time frame: up to 2 weeks
  description: Safety of the Treatment defined as the proportion of study participants free of serious adverse device effects and unanticipated serious adverse device effects (SADE and USADE) assessed via a safety questionnaire and medical evaluation.
  measure: Safety and comfort: questionnaire
  time frame: up to 2 weeks
  description: Adverse Events and comfort of tACS and the medical device are reported by questionnaires following stimulation of each target region at visit °3 & °4 and following sequential stimulation of multiple target regions at visit °5 & °6.
  measure: Evaluation of functional impact of tACS on Attention and Concentration: d2-R attention test
  time frame: up to 2 weeks
  description: Changes in d2-R attention test are reported to document the functional impact of tACS on concentration and attention before and after stimulation of each target region at visit °3 & °4 and before and after sequential stimulation of multiple target regions at visit °5 & °6.
  The d2-R attention test measures processing speed, rule compliance, and quality of performance as estimation of attention and concentration and scores them as the following separate items: speed, concentration, carefulness. Each item is scored from 20-80. A higher score indicates better performance.
  measure: Evaluation of functional impact of tACS on oscillatory activity: Electroencephalography (EEG)
  time frame: up to 2 weeks
  description: Quantification of EEG measurements to document the functional impact of tACS on oscillatory activity in individual frequency bands (delta, theta, alpha, beta, gamma) and EEG-biomarkers (alpha peak frequency, Vigilance) before and after stimulation of each target region at visit °3 & °4 & °5 & °6.
  measure: Cognitive Evaluation: Montreal Cognitive Assessment (MoCA)
  time frame: up to 2 weeks
  description: MoCA scores are documented before and after visit °3 and after visit °6 to evaluate the impact of repeated tACS on cognitive performance.
  The MoCA has a total scoring range of 0-30, with the score based on the number of correct answers made in each of the 7 following items: Visuospatial/Executive, Naming, Memory/delayed recall, Attention, Language, Abstraction, Orientation. Sub-scores and total score are reported.
  A lower total score indicate greater cognitive impairment.
  measure: Participant coherence and satisfaction questionnaire
  time frame: up to 2 weeks
  description: The subjective impression and satisfaction of the participant regarding the device and the intervention is documented using a one-time questionnaire at the end of the study.
  arm group label: 60 min session of 40Hz tACS by Miamind Neurostimulator
  arm group type: Experimental
  description: The clinical study will enroll eight (8) participants who will undergo four (4) tACS sessions (one per day) within 4 consecutive days. The tACS intervention will last 60 min in total. The stimulation frequency will be 40 Hz with max 1 mA/electrode and total of max 2 mA across all active electrodes (peak-to-baseline).
  intervention type: Device
  intervention name: Personalized Miamind Neurostimulator
  description: 60 min. 40 Hz max. 1mA / electrode & total of max. 2 mA across all electrodes. 30- s ramp-up personalised intervention based on individual modelling of electric field distribution to maximise therapeutic effect in the target region. Three target regions, consecutively stimulated (20min each).
  arm group label: 60 min session of 40Hz tACS by Miamind Neurostimulator
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Alois Hopf, PhD
  role: Study Chair
  affiliation: Bottneuro AG
  last name: Alois Hopf, PhD
  phone: +41 61 515 00 43
  email: alois.hopf@bottneuro.ch
  last name: Bekim Osmani, PhD
  phone: +41 61 515 00 43
  email: bekim.osmani@bottneuro.ch
  facility: 
  contact: 
  contact backup: 
  country: Switzerland
  url: http://bottneuro.ch/en
  description: Bottneuro Website
  citation: Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.
  PMID: 28709880
  citation: Nissim NR, McAfee DC, Edwards S, Prato A, Lin JX, Lu Z, Coslett HB, Hamilton RH. Efficacy of Transcranial Alternating Current Stimulation in the Enhancement of Working Memory Performance in Healthy Adults: A Systematic Meta-Analysis. Neuromodulation. 2023 Jun;26(4):728-737. doi: 10.1016/j.neurom.2022.12.014. Epub 2023 Feb 8.
  PMID: 36759231
  citation: Menardi A, Rossi S, Koch G, Hampel H, Vergallo A, Nitsche MA, Stern Y, Borroni B, Cappa SF, Cotelli M, Ruffini G, El-Fakhri G, Rossini PM, Dickerson B, Antal A, Babiloni C, Lefaucheur JP, Dubois B, Deco G, Ziemann U, Pascual-Leone A, Santarnecchi E. Toward noninvasive brain stimulation 2.0 in Alzheimer's disease. Ageing Res Rev. 2022 Mar;75:101555. doi: 10.1016/j.arr.2021.101555. Epub 2021 Dec 30.
  PMID: 34973457
  citation: Benussi A, Cantoni V, Grassi M, Brechet L, Michel CM, Datta A, Thomas C, Gazzina S, Cotelli MS, Bianchi M, Premi E, Gadola Y, Cotelli M, Pengo M, Perrone F, Scolaro M, Archetti S, Solje E, Padovani A, Pascual-Leone A, Borroni B. Increasing Brain Gamma Activity Improves Episodic Memory and Restores Cholinergic Dysfunction in Alzheimer's Disease. Ann Neurol. 2022 Aug;92(2):322-334. doi: 10.1002/ana.26411. Epub 2022 Jun 6.
  PMID: 35607946
  citation: Dhaynaut M, Sprugnoli G, Cappon D, Macone J, Sanchez JS, Normandin MD, Guehl NJ, Koch G, Paciorek R, Connor A, Press D, Johnson K, Pascual-Leone A, El Fakhri G, Santarnecchi E. Impact of 40 Hz Transcranial Alternating Current Stimulation on Cerebral Tau Burden in Patients with Alzheimer's Disease: A Case Series. J Alzheimers Dis. 2022;85(4):1667-1676. doi: 10.3233/JAD-215072.
  PMID: 34958021
  citation: Sprugnoli G, Munsch F, Cappon D, Paciorek R, Macone J, Connor A, El Fakhri G, Salvador R, Ruffini G, Donohoe K, Shafi MM, Press D, Alsop DC, Pascual Leone A, Santarnecchi E. Impact of multisession 40Hz tACS on hippocampal perfusion in patients with Alzheimer's disease. Alzheimers Res Ther. 2021 Dec 20;13(1):203. doi: 10.1186/s13195-021-00922-4.
  PMID: 34930421
  responsible party type: Sponsor