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/NCT05984524</url>
    </required_header>
    <id_info>
      <org_study_id>NortheasternMINDLabGammaMBI</org_study_id>
      <nct_id>NCT05984524</nct_id>
    </id_info>
    <brief_title>Gamma-Music Based Intervention for Mild Alzheimer's Disease</brief_title>
    <acronym>NUGammaMBI</acronym>
    <official_title>Gamma-Music Based Intervention for Mild Alzheimer's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Northeastern University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Northeastern University</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 study will test and refine a novel brain-stimulation tool using gamma-frequency lights&#xD;
        coupled with self-selected music for a gamma-music-based intervention for participants with&#xD;
        mild Alzheimer's Disease. Results will yield a gamma-stimulation protocol that reliably&#xD;
        influences brain activity (Aim 1), is adaptive, motivating and rewarding to use (Aim 2), and&#xD;
        will generate predictions as to who might benefit the most from gamma-MBI (Aim 3). By&#xD;
        bridging the gap between neurostimulation and behavioral intervention by combining music&#xD;
        therapy with gamma- band neurostimulation, the present project aims to find a sustainable&#xD;
        intervention that delays the progression of AD.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Alzheimer's Disease (AD) is characterized by cognitive deficits such as memory loss, as well&#xD;
        as deficits in the motivation that drives daily activities. These cognitive and motivational&#xD;
        deficits are linked to widespread neuronal and synaptic atrophy, coupled with aggregated&#xD;
        extracellular Aβ-plaque and tau deposits, and atypical neural activity across multiple&#xD;
        frequencies. Recent work in mouse models of AD have shown that inducing gamma oscillations&#xD;
        with a non-invasive gamma-frequency (40 Hz) light-flickering and auditory tone-stimulation&#xD;
        regimes reduced Aβ plaques and improved spatial and recognition memory. In humans, restoring&#xD;
        gamma-frequency activity while preserving its phase-amplitude coupling with theta-band&#xD;
        activity are shown to recover human memory performance in older adults, and in patients with&#xD;
        mild AD, thus offering a promising route towards a novel therapy that can prevent brain&#xD;
        atrophy while improving cognition. Despite their recent successes, it is a major challenge to&#xD;
        translate gamma-frequency neurostimulation from a laboratory study to a behavioral&#xD;
        intervention. The goal is to promote healthy neurocognitive aging using lifestyle&#xD;
        interventions; in particular, interventions that sustainably elevate mood and reward&#xD;
        motivated behavior while encouraging social bonding may be most promising in slowing the&#xD;
        progression of AD. Music listening engages multiple brain networks involved in sensory&#xD;
        processing, movement, language, attention, learning and memory, emotion and reward, and&#xD;
        social connectedness. Music-Based Interventions (MBIs) have the potential to manage symptoms,&#xD;
        slow disease progression, and improve quality of life. This study will test a novel protocol&#xD;
        for music-based brain stimulation, gamma-MBI: gamma-light stimulation that automatically&#xD;
        adapts to music-based intervention. Harnessing the fact that music listening is an&#xD;
        intrinsically rewarding activity, the study uses music as a carrier for gamma sensory&#xD;
        stimulation. As music contains theta-band acoustic energy, music listening is a form of&#xD;
        theta- band noninvasive brain stimulation. A novel brain-stimulation tool will be tested&#xD;
        using gamma-frequency lights coupled with self-selected music for a gamma-music-based&#xD;
        intervention for participants with mild Alzheimer's Disease. Results will yield a&#xD;
        gamma-stimulation protocol that reliably influences brain activity (Aim 1), is adaptive,&#xD;
        motivating and rewarding to use (Aim 2), and will generate predictions as to who might&#xD;
        benefit the most from gamma-MBI (Aim 3). By bridging the gap between neurostimulation and&#xD;
        behavioral intervention by combining music therapy with gamma-band neurostimulation, the&#xD;
        present project aims to find a sustainable intervention that delays the progression of AD.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2022</start_date>
    <completion_date type="Anticipated">June 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomized Control Trial</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Sham placebo control intervention</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>EEG activity</measure>
      <time_frame>1 hour</time_frame>
      <description>Gamma-band EEG activity</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ADAS-Cog 14</measure>
      <time_frame>8 weeks</time_frame>
      <description>cognitive component of iADRS</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Alzheimer Disease</condition>
    <arm_group>
      <arm_group_label>Gamma</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>8-week music-based intervention with gamma lights</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>8-week music-based intervention with control lights</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Gamma-Music Based Intervention</intervention_name>
      <description>Gamma or Control lights with Music-Based Intervention for 8 week period</description>
      <arm_group_label>Control</arm_group_label>
      <arm_group_label>Gamma</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Mild AD participants will be ages 55-90, amnestic (single or multiple domain) who perform&#xD;
          below an education- adjusted cut-off score on the Logical Memory II subscale delayed&#xD;
          paragraph recall of the Wechsler Memory Scale-Revised (WMS-R LM-IIa) (Wechsler 1987) (≥16&#xD;
          years: ≤8; 8-15 years: ≤4; 0-7 years: ≤2), have a CDR global score of 0.5 (with a memory&#xD;
          box score of 0.5 or 1), have an MMSE score of 20-24, and have preserved instrumental&#xD;
          activities of daily living (ADL) as determined by the Alzheimer's Disease Cooperative Study&#xD;
          ADL Prevention Instrument (ADCS ADL-PI). All participants will be medically stable.&#xD;
          Participants will not have significant cerebrovascular disease determined by history of&#xD;
          stroke, and will have a Modified Hachinski Ischemic score (Rosen et al. 1980) of ≤ 4.&#xD;
          Participants will not have significant psychiatric disorders including a Geriatric&#xD;
          Depression Scale (long form) (Yesavage et al. 1982) of ≤10, and will not have a history of&#xD;
          substance or alcohol abuse. All participants must be on stable doses of any medications&#xD;
          with psychotropic effects (including cholinesterase inhibitors, memantine, and&#xD;
          antidepressants) for at least 3 months prior to randomization. Participants will be&#xD;
          screened to be amyloid positive via plasma test. They must also have no contraindications&#xD;
          to MRI scanning, and will have a study partner who is able to provide collateral&#xD;
          information about the participant. A pure tone audiogram will be administered to ensure&#xD;
          that participants have no more than mild levels of hearing loss (&lt;40dB). If a subject fails&#xD;
          audiometric screening, they will be excluded from the study and provided with a list of&#xD;
          audiologists. An Institutional Review Board (IRB) approved telephone screen will be used&#xD;
          for demographic information, study inclusion/exclusion criteria and MRI contraindications.&#xD;
          Participants will complete an MRI screening questionnaire before each MRI session.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>95 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Northeastern University</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02115</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Elham Ghabour, PhD</last_name>
        <phone>617-373-7915</phone>
        <email>e.ghabbour@northeastern.edu</email>
      </contact>
      <investigator>
        <last_name>Psyche Loui, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alzheimer Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05984524
  org study id: NortheasternMINDLabGammaMBI
  nct id: NCT05984524
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study will test and refine a novel brain-stimulation tool using gamma-frequency lights
        coupled with self-selected music for a gamma-music-based intervention for participants with
        mild Alzheimer's Disease. Results will yield a gamma-stimulation protocol that reliably
        influences brain activity (Aim 1), is adaptive, motivating and rewarding to use (Aim 2), and
        will generate predictions as to who might benefit the most from gamma-MBI (Aim 3). By
        bridging the gap between neurostimulation and behavioral intervention by combining music
        therapy with gamma- band neurostimulation, the present project aims to find a sustainable
        intervention that delays the progression of AD.
  Alzheimer's Disease (AD) is characterized by cognitive deficits such as memory loss, as well
        as deficits in the motivation that drives daily activities. These cognitive and motivational
        deficits are linked to widespread neuronal and synaptic atrophy, coupled with aggregated
        extracellular Aβ-plaque and tau deposits, and atypical neural activity across multiple
        frequencies. Recent work in mouse models of AD have shown that inducing gamma oscillations
        with a non-invasive gamma-frequency (40 Hz) light-flickering and auditory tone-stimulation
        regimes reduced Aβ plaques and improved spatial and recognition memory. In humans, restoring
        gamma-frequency activity while preserving its phase-amplitude coupling with theta-band
        activity are shown to recover human memory performance in older adults, and in patients with
        mild AD, thus offering a promising route towards a novel therapy that can prevent brain
        atrophy while improving cognition. Despite their recent successes, it is a major challenge to
        translate gamma-frequency neurostimulation from a laboratory study to a behavioral
        intervention. The goal is to promote healthy neurocognitive aging using lifestyle
        interventions; in particular, interventions that sustainably elevate mood and reward
        motivated behavior while encouraging social bonding may be most promising in slowing the
        progression of AD. Music listening engages multiple brain networks involved in sensory
        processing, movement, language, attention, learning and memory, emotion and reward, and
        social connectedness. Music-Based Interventions (MBIs) have the potential to manage symptoms,
        slow disease progression, and improve quality of life. This study will test a novel protocol
        for music-based brain stimulation, gamma-MBI: gamma-light stimulation that automatically
        adapts to music-based intervention. Harnessing the fact that music listening is an
        intrinsically rewarding activity, the study uses music as a carrier for gamma sensory
        stimulation. As music contains theta-band acoustic energy, music listening is a form of
        theta- band noninvasive brain stimulation. A novel brain-stimulation tool will be tested
        using gamma-frequency lights coupled with self-selected music for a gamma-music-based
        intervention for participants with mild Alzheimer's Disease. Results will yield a
        gamma-stimulation protocol that reliably influences brain activity (Aim 1), is adaptive,
        motivating and rewarding to use (Aim 2), and will generate predictions as to who might
        benefit the most from gamma-MBI (Aim 3). By bridging the gap between neurostimulation and
        behavioral intervention by combining music therapy with gamma-band neurostimulation, the
        present project aims to find a sustainable intervention that delays the progression of AD.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized Control Trial
  primary purpose: Other
  masking: Single (Participant)
  masking description: Sham placebo control intervention
  measure: EEG activity
  time frame: 1 hour
  description: Gamma-band EEG activity
  measure: ADAS-Cog 14
  time frame: 8 weeks
  description: cognitive component of iADRS
  arm group label: Gamma
  arm group type: Experimental
  description: 8-week music-based intervention with gamma lights
  arm group label: Control
  arm group type: Placebo Comparator
  description: 8-week music-based intervention with control lights
  intervention type: Behavioral
  intervention name: Gamma-Music Based Intervention
  description: Gamma or Control lights with Music-Based Intervention for 8 week period
  arm group label: Control
  arm group label: Gamma
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 95 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Alzheimer Disease
  sharing ipd: Undecided