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/NCT06003127</url>
    </required_header>
    <id_info>
      <org_study_id>2023P001821</org_study_id>
      <nct_id>NCT06003127</nct_id>
    </id_info>
    <brief_title>REcovery From DEXmedetomidine-induced Unconsciousness</brief_title>
    <acronym>REDEX</acronym>
    <official_title>REcovery From DEXmedetomidine-induced Unconsciousness</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Massachusetts General Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This pilot study in healthy volunteers aims to determine if biological sex has an impact on&#xD;
        recovery from dexmedetomidine-induced unconsciousness, and if transcranial magnetic&#xD;
        stimulation combined with electroencephalography (TMS-EEG) can be used to measure brain&#xD;
        complexity during dexmedetomidine sedation without arousing study participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time to return of responsiveness</measure>
      <time_frame>Up to 120 minutes</time_frame>
      <description>The time to return of responsiveness will be measured in minutes and from the moment of dexmedetomidine discontinuation to the return of hand squeezing (five times in a row) in response to auditory stimulation.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Anesthesia</condition>
    <condition>Healthy</condition>
    <condition>Consciousness, Level Altered</condition>
    <arm_group>
      <arm_group_label>Transcranial Magnetic Stimulation (TMS) Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This arm will undergo TMS during the study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-Transcranial Magnetic Stimulation (TMS) Arm</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This arm will not undergo TMS during the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcranial Magnetic Stimulation</intervention_name>
      <description>Repetitive transcranial magnetic stimulation and measurement of related evoked potentials in the EEG.</description>
      <arm_group_label>Transcranial Magnetic Stimulation (TMS) Arm</arm_group_label>
      <other_name>TMS-EEG</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Between the ages of 18 to 45&#xD;
  &#xD;
            -  Normal body weight and habitus, body mass index (BMI) 18 to 30 kg/m2&#xD;
  &#xD;
            -  Non-smoker&#xD;
  &#xD;
            -  No history of taking stimulants or substance abuse&#xD;
  &#xD;
            -  For women: use of hormonal contraception&#xD;
  &#xD;
            -  American Society of Anesthesiologists (ASA) physical status classification 1 (ASA 1)&#xD;
  &#xD;
            -  Fluent in English (sufficient to communicate with the study team and understand the&#xD;
               consent form)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Neurologic: epilepsy or positive history of a seizure, stroke, central disorders of&#xD;
               hypersomnolence, neuroimmunological disorder (e.g. multiple sclerosis), Meniere's&#xD;
               disease, Parkinson's disease, peripheral neuropathy, no significant visual or hearing&#xD;
               impairments, findings in the clinical examination suggesting a neurologic disorder&#xD;
  &#xD;
            -  Psychiatric: history or treatment for an active psychiatric problem (including&#xD;
               Attention-Deficit / Hyperactivity Disorder (ADHD) and anxiety disorder)&#xD;
  &#xD;
            -  Cardiovascular: hypertension, symptomatic hypotension or bradycardia, myocardial&#xD;
               infarction, coronary artery disease, peripheral vascular disease, dysrhythmias,&#xD;
               congestive heart failure, cardiomyopathy, valvular disease, familial history of sudden&#xD;
               cardiac death&#xD;
  &#xD;
            -  Respiratory: bronchitis, asthma, chronic obstructive pulmonary disease, smoking,&#xD;
               shortness of breath, sleep apnea&#xD;
  &#xD;
            -  Gastrointestinal: esophageal reflux, hiatal hernia, ulcer&#xD;
  &#xD;
            -  Hepatic: hepatitis, jaundice, ascites&#xD;
  &#xD;
            -  Renal: acute or chronic severe renal insufficiency&#xD;
  &#xD;
            -  Reproductive: pregnancy, breast-feeding&#xD;
  &#xD;
            -  Endocrine: diabetes, thyroid disease, adrenal gland disease&#xD;
  &#xD;
            -  Hematologic: blood dyscrasias, anemia, coagulopathies&#xD;
  &#xD;
            -  Musculoskeletal: prior surgery or trauma to head neck or face, arthritis, personal or&#xD;
               family history of malignant hyperthermia&#xD;
  &#xD;
            -  Medications: regular use of prescription and non-prescription medications expected to&#xD;
               affect central nervous function, anticoagulant or thrombocyte-aggregation inhibiting&#xD;
               therapy; exception: oral hormonal contraception&#xD;
  &#xD;
            -  Allergies: dexmedetomidine, phenylephrine, betablockers (including labetalol and&#xD;
               esmolol), hydralazine, glycopyrrolate&#xD;
  &#xD;
          Potential participants will not be enrolled in our study if they fail to pass a drug test&#xD;
          that screens for the following: Cocaine (COC), d-Amphetamine (AMP), d-Methamphetamine&#xD;
          (Mamp), Tetrahydrocannabinol (THC), Methadone (MTD), Opiates (OPI), Phencyclidine (PCP),&#xD;
          Barbiturates (BAR), Benzodiazepines (BZO), Oxycodone (OXY)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ken Solt, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Massachusetts General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ken Solt, MD</last_name>
      <phone>1-617-726-4359</phone>
      <email>ksolt@mgh.harvard.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>David Schreier, MD, PhD</last_name>
      <email>dschreier@mgh.harvard.edu</email>
    </overall_contact_backup>
    <reference>
      <citation>Vincent KF, Mallari OG, Dillon EJ, Stewart VG, Cho AJ, Dong Y, Edlow AG, Ichinose F, Xie Z, Solt K. Oestrous cycle affects emergence from anaesthesia with dexmedetomidine, but not propofol, isoflurane, or sevoflurane, in female rats. Br J Anaesth. 2023 Jul;131(1):67-78. doi: 10.1016/j.bja.2023.03.025. Epub 2023 May 2.</citation>
      <PMID>37142466</PMID>
    </reference>
    <reference>
      <citation>Kato R, Zhang ER, Mallari OG, Moody OA, Vincent KF, Melonakos ED, Siegmann MJ, Nehs CJ, Houle TT, Akeju O, Solt K. D-Amphetamine Rapidly Reverses Dexmedetomidine-Induced Unconsciousness in Rats. Front Pharmacol. 2021 May 18;12:668285. doi: 10.3389/fphar.2021.668285. eCollection 2021.</citation>
      <PMID>34084141</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Ken Solt</investigator_full_name>
      <investigator_title>Associate Professor of Anesthesia</investigator_title>
    </responsible_party>
    <keyword>Dexmedetomidine</keyword>
    <keyword>EEG</keyword>
    <keyword>Transcranial magnetic stimulation</keyword>
    <keyword>Cognition</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Unconsciousness</mesh_term>
      <mesh_term>Consciousness Disorders</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/NCT06003127
  org study id: 2023P001821
  nct id: NCT06003127
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This pilot study in healthy volunteers aims to determine if biological sex has an impact on
        recovery from dexmedetomidine-induced unconsciousness, and if transcranial magnetic
        stimulation combined with electroencephalography (TMS-EEG) can be used to measure brain
        complexity during dexmedetomidine sedation without arousing study participants.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Time to return of responsiveness
  time frame: Up to 120 minutes
  description: The time to return of responsiveness will be measured in minutes and from the moment of dexmedetomidine discontinuation to the return of hand squeezing (five times in a row) in response to auditory stimulation.
  arm group label: Transcranial Magnetic Stimulation (TMS) Arm
  arm group type: Experimental
  description: This arm will undergo TMS during the study.
  arm group label: Non-Transcranial Magnetic Stimulation (TMS) Arm
  arm group type: No Intervention
  description: This arm will not undergo TMS during the study.
  intervention type: Device
  intervention name: Transcranial Magnetic Stimulation
  description: Repetitive transcranial magnetic stimulation and measurement of related evoked potentials in the EEG.
  arm group label: Transcranial Magnetic Stimulation (TMS) Arm
  other name: TMS-EEG
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ken Solt, MD
  role: Principal Investigator
  affiliation: Massachusetts General Hospital
  last name: Ken Solt, MD
  phone: 1-617-726-4359
  email: ksolt@mgh.harvard.edu
  last name: David Schreier, MD, PhD
  email: dschreier@mgh.harvard.edu
  citation: Vincent KF, Mallari OG, Dillon EJ, Stewart VG, Cho AJ, Dong Y, Edlow AG, Ichinose F, Xie Z, Solt K. Oestrous cycle affects emergence from anaesthesia with dexmedetomidine, but not propofol, isoflurane, or sevoflurane, in female rats. Br J Anaesth. 2023 Jul;131(1):67-78. doi: 10.1016/j.bja.2023.03.025. Epub 2023 May 2.
  PMID: 37142466
  citation: Kato R, Zhang ER, Mallari OG, Moody OA, Vincent KF, Melonakos ED, Siegmann MJ, Nehs CJ, Houle TT, Akeju O, Solt K. D-Amphetamine Rapidly Reverses Dexmedetomidine-Induced Unconsciousness in Rats. Front Pharmacol. 2021 May 18;12:668285. doi: 10.3389/fphar.2021.668285. eCollection 2021.
  PMID: 34084141
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Ken Solt
  investigator title: Associate Professor of Anesthesia
  mesh term: Unconsciousness
  mesh term: Consciousness Disorders
  sharing ipd: Undecided