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/NCT06017232</url>
    </required_header>
    <id_info>
      <org_study_id>20224665</org_study_id>
      <nct_id>NCT06017232</nct_id>
    </id_info>
    <brief_title>Telerehabilitation for Dysautonomia in Parkinson's Disease</brief_title>
    <acronym>PKT</acronym>
    <official_title>The ParkinSANTÉlé Study: A Multicomponent Telerehabilitation Program to Improve Cardiovascular Health in People With Parkinson's Disease With a Clinical Diagnosis of Dysautonomia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Université de Sherbrooke</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Centre de Recherche sur le Vieillissement (CdRV)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Université de Sherbrooke</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>
        People diagnosed with Parkinson's Disease (PD) exhibit a combination of motor and non-motor&#xD;
        symptoms, with the latter posing challenges in terms of identification and management. These&#xD;
        non-motor symptoms tend to manifest before the motor symptoms and progressively worsen over&#xD;
        time, significantly impacting the symptoms and everyday life activities of those affected.&#xD;
        However, there remains a noticeable lack of scientific literature addressing the assessment&#xD;
        and rehabilitation of cardiovascular dysautonomia in PD patients. Thus, our research aims to&#xD;
        address this gap by pursuing the following objectives: 1) assess the feasibility,&#xD;
        acceptability, and potential effectiveness of a hybrid telerehabilitation program designed to&#xD;
        target cardiovascular health in individuals with Parkinson's disease; and 2) characterize&#xD;
        cardiovascular dysautonomia using non-invasive measurements of cardiovascular and autonomic&#xD;
        nervous system (ANS) function and self-reported symptom assessments.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This pilot clinical trial employs mixed methods and aims to recruit 16 participants meeting&#xD;
        the criteria of stage 1 to 3 Parkinson's disease according to the Hoehn and Yahr scale, aged&#xD;
        50 or above, under optimized drug therapy, having home internet access, and without exercise&#xD;
        contraindications, but exhibiting cardiovascular dysautonomia based on positive clinical&#xD;
        results from active orthostatic hypotension maneuver, with or without reported symptoms&#xD;
        and/or SCOPA-AUT questionnaire score ≥ 2/3 items. The 12-week telerehabilitation program&#xD;
        comprises three weekly sessions, encompassing different exercise modalities to improve walk&#xD;
        capacity (aerobic, strength, balance, coordination, flexibility) and education on symptom&#xD;
        management. A progressive increase in autonomy is implemented, starting with&#xD;
        synchronous/asynchronous sessions of 3/0 in week 1 to 0/3 in week 12. Feasibility&#xD;
        (recruitment, adherence, retention), acceptability (questionnaire, semi-structured&#xD;
        interviews), and potential effectiveness on motor (walking, mobility, balance) and non-motor&#xD;
        aspects (pain and cardiovascular dysautonomia) will be measured before and after the&#xD;
        intervention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 13, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2024</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 study design is a pre-post without a control group</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of the implementation</measure>
      <time_frame>12 weeks</time_frame>
      <description>This will be evaluated by the percentage of participants that accepted to participate in the study (recruitment rate), percentage who completed the intervention (retention rate) and number of completed session in relation to the anticipated number of sessions (adherence).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fidelity</measure>
      <time_frame>12 weeks</time_frame>
      <description>The measurement of fidelity will involve tracking the frequency of significant modifications made to the planned protocol. These alterations include changes in the exercise order, the introduction of additional exercises not originally part of the program, and variations in session duration and completion of educational components.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability</measure>
      <time_frame>12 weeks</time_frame>
      <description>The satisfaction of the participants will be evaluated with a questionnaire (14 questions). The questionnaire will assess patients' satisfaction with the professional, the services and the organization - Telemedicine Satisfaction. Qualitative open-ended questions will be used to determine appreciation and challenges encountered.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dysautonomia Symptoms</measure>
      <time_frame>12 weeks</time_frame>
      <description>Scale for Outcomes in Parkinson's disease for Autonomic symptoms (SCOPA-AUT) with maximum score 69, with the score for each item ranging from 0 (never experiencing the symptom) to 3 (often experiencing the symptom).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Impact of dysautonomia symptoms</measure>
      <time_frame>12 weeks</time_frame>
      <description>Orthostatic Hypotension Questionnaire (OHQ): The questionnaire is divided into 2 parts: Part I, Symptom Assessment (OHSA), consisted of 6 questions, each rat-ing the intensity of one characteristic symptom [ 1. Dizziness, lightheadedness, feeling faint, or feeling Iike you might black out; 2. Problems with vision (blurring, seeing spots, tunnel vision, etc.); 3. Generalized weakness; 4. Fatigue; 5. Trouble concentrating; 6. Head/neck dis-comfort] and Part Il, Daily Activity Scale (OHDAS), consisted of 4 questions that assessed the impact of NOH symptoms on daily activities.&#xD;
  Items scored on an 11-point scale (0 to 10), with O indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. The composite OHQ score is calculated by averaging the OHSAS and the OHDAS.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Exercise capacity</measure>
      <time_frame>12 weeks</time_frame>
      <description>Six-minute walk test (performance and physiological responses)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Severity of pain and impact on functioning</measure>
      <time_frame>12 weeks</time_frame>
      <description>Brief Pain Inventory: Participants are asked to rate their current symptoms, their average experiences of pain, and the minimum and maximum intensities of their symptoms on scales that range from 0 to 10. A total pain severity score can be found by averaging these items or a single item can be treated as the primary outcome measure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Type of pain</measure>
      <time_frame>12 weeks</time_frame>
      <description>Neuropathic pain DN4 Questionnaire: Items are scored based on a yes (1 point) /no (0 points) answer. This leads to a score range of 0-10 when the symptoms (range 0-7 points) as well as the signs (range 0-3 points) items are included.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived quality of life</measure>
      <time_frame>12 weeks</time_frame>
      <description>Parkinson's Disease Questionnaire 8 items (PDQ-8, scored 0-32, higher score indicating the worst quality of life)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lower-limb function</measure>
      <time_frame>12 weeks</time_frame>
      <description>Lower Extremity Functional Scale (LEFS, scored 0-32, higher score indicating less difficulty)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mobility in the community</measure>
      <time_frame>12 weeks</time_frame>
      <description>Life-space mobility (French-Canadian version) (partial scores are summed to produce a composite score 0-120, higher score indicating more mobility)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mobility</measure>
      <time_frame>12 weeks</time_frame>
      <description>Timed Up and Go</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Balance</measure>
      <time_frame>12 weeks</time_frame>
      <description>Berg balance scale (scored 0-56, higher score indicating more balance)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Walking capacity</measure>
      <time_frame>12 weeks</time_frame>
      <description>10-meter walk test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lower-limb strength and power</measure>
      <time_frame>12 weeks</time_frame>
      <description>5-repetition sit to stand test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fine motor dexterity and coordination</measure>
      <time_frame>12 weeks</time_frame>
      <description>Purdue Pegboard Test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular health</measure>
      <time_frame>12 weeks</time_frame>
      <description>24-hour ambulatory blood pressure monitoring (Mobil-O-Graph® 24hr ABPM) (systolic and diastolic blood pressure)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sympathetic nervous innervation of the skin</measure>
      <time_frame>12 weeks</time_frame>
      <description>Electrodermal activity (Galvanic skin response) with PowerLab ADInstruments: Results are presented as the difference between the maximum of the electrodermal response (or of sweating, therefore of skin conductivity) and the minimum of the electrodermal response (delta values).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Autonomic modulation</measure>
      <time_frame>12 weeks</time_frame>
      <description>Heart rate variability (HRV) (supine 6 minutes and upright position 6 minutes)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">16</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group of participants receiving the hybrid telerehabilitation intervention</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Hybrid telerehabilitation program</intervention_name>
      <description>The telerehabilitation program lasts 12 week (3 per week). The program includes aerobic, strength, coordination, balance, flexibility, and breathing exercises, in addition to educational components focused on disease management.&#xD;
  This hybrid program incorporates both supervised and unsupervised sessions. A progressive approach from synchronous (supervised) to asynchronous (unsupervised) sessions is adopted.&#xD;
  Each session is structured into 4 components: Warm-up; Muscle strengthening, coordination, and balance; Flexibility; and Breathing exercises.&#xD;
  Participants are asked to maintain a log of their aerobic activity, recording details such as the type of activity, duration, and intensity. The aim is to align with the recommended aerobic physical activity guidelines (150 min/week). Weekly assessments are conducted to provide personalized guidance based on individual progress.&#xD;
  Also, participants engage in weekly educational videos that cover a diverse range of PD-related topics.</description>
      <arm_group_label>Intervention group</arm_group_label>
      <other_name>OpenTera telerehabilitation</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with PD (1 to 3 on Hoeh&amp;Yahr)&#xD;
  &#xD;
            -  Patients under treatment with optimized drug therapy. Medication is stable for at&#xD;
               least 1 month&#xD;
  &#xD;
            -  Patients with access to the internet&#xD;
  &#xD;
            -  Speaking French or English&#xD;
  &#xD;
            -  50 years or older&#xD;
  &#xD;
            -  Patients having cardiovascular dysautonomia according to the clinical criteria: supine&#xD;
               hypertension (SH) (≥140/90 mmHg) and/or orthostatic hypotension (OH) (a drop of&#xD;
               systolic blood pressure ≥ 20 mmHg and/or diastolic blood pressure ≥ 10 mmHg during the&#xD;
               active orthostatic hypotension test).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Major cognitive impairment (Montreal Cognitive Assessment, score ≤ 24)&#xD;
  &#xD;
            -  Neurological disorders other than PD&#xD;
  &#xD;
            -  Musculoskeletal or cardiopulmonary disorders preventing physical activity,&#xD;
               contraindication to physical activity, or presence of a cardiac pacemaker.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Livia Pinheiro Carvalho, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Université de Sherbrooke</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Livia Pinheiro Carvalho, PhD</last_name>
      <phone>819 780-2220</phone>
      <phone_ext>71095</phone_ext>
      <email>livia.pinheiro.carvalho@usherbrooke.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Leo Crepin, MSc(cand)</last_name>
      <email>leo.crepin@usherbrooke.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Centre de Recherche sur le Vieillissement</name>
        <address>
          <city>Sherbrooke</city>
          <state>Quebec</state>
          <zip>J1H 4C4</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Elise Laperle</last_name>
        <phone>819 780-2220</phone>
        <phone_ext>45132</phone_ext>
        <email>direction-cdrv@usherbrooke.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>virtual rehabilitation</keyword>
    <keyword>exercise</keyword>
    <keyword>parkinsonism</keyword>
    <keyword>cardiovascular</keyword>
    <keyword>autonomic nervous system</keyword>
    <keyword>cardiorespiratory</keyword>
    <keyword>physical therapy</keyword>
    <keyword>physiotherapy</keyword>
    <keyword>physical activity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
      <mesh_term>Primary Dysautonomias</mesh_term>
      <mesh_term>Autonomic Nervous System Diseases</mesh_term>
    </condition_browse>
    <!-- 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/NCT06017232
  org study id: 20224665
  nct id: NCT06017232
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  People diagnosed with Parkinson's Disease (PD) exhibit a combination of motor and non-motor
        symptoms, with the latter posing challenges in terms of identification and management. These
        non-motor symptoms tend to manifest before the motor symptoms and progressively worsen over
        time, significantly impacting the symptoms and everyday life activities of those affected.
        However, there remains a noticeable lack of scientific literature addressing the assessment
        and rehabilitation of cardiovascular dysautonomia in PD patients. Thus, our research aims to
        address this gap by pursuing the following objectives: 1) assess the feasibility,
        acceptability, and potential effectiveness of a hybrid telerehabilitation program designed to
        target cardiovascular health in individuals with Parkinson's disease; and 2) characterize
        cardiovascular dysautonomia using non-invasive measurements of cardiovascular and autonomic
        nervous system (ANS) function and self-reported symptom assessments.
  This pilot clinical trial employs mixed methods and aims to recruit 16 participants meeting
        the criteria of stage 1 to 3 Parkinson's disease according to the Hoehn and Yahr scale, aged
        50 or above, under optimized drug therapy, having home internet access, and without exercise
        contraindications, but exhibiting cardiovascular dysautonomia based on positive clinical
        results from active orthostatic hypotension maneuver, with or without reported symptoms
        and/or SCOPA-AUT questionnaire score ≥ 2/3 items. The 12-week telerehabilitation program
        comprises three weekly sessions, encompassing different exercise modalities to improve walk
        capacity (aerobic, strength, balance, coordination, flexibility) and education on symptom
        management. A progressive increase in autonomy is implemented, starting with
        synchronous/asynchronous sessions of 3/0 in week 1 to 0/3 in week 12. Feasibility
        (recruitment, adherence, retention), acceptability (questionnaire, semi-structured
        interviews), and potential effectiveness on motor (walking, mobility, balance) and non-motor
        aspects (pain and cardiovascular dysautonomia) will be measured before and after the
        intervention.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: The study design is a pre-post without a control group
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Feasibility of the implementation
  time frame: 12 weeks
  description: This will be evaluated by the percentage of participants that accepted to participate in the study (recruitment rate), percentage who completed the intervention (retention rate) and number of completed session in relation to the anticipated number of sessions (adherence).
  measure: Fidelity
  time frame: 12 weeks
  description: The measurement of fidelity will involve tracking the frequency of significant modifications made to the planned protocol. These alterations include changes in the exercise order, the introduction of additional exercises not originally part of the program, and variations in session duration and completion of educational components.
  measure: Acceptability
  time frame: 12 weeks
  description: The satisfaction of the participants will be evaluated with a questionnaire (14 questions). The questionnaire will assess patients' satisfaction with the professional, the services and the organization - Telemedicine Satisfaction. Qualitative open-ended questions will be used to determine appreciation and challenges encountered.
  measure: Dysautonomia Symptoms
  time frame: 12 weeks
  description: Scale for Outcomes in Parkinson's disease for Autonomic symptoms (SCOPA-AUT) with maximum score 69, with the score for each item ranging from 0 (never experiencing the symptom) to 3 (often experiencing the symptom).
  measure: Impact of dysautonomia symptoms
  time frame: 12 weeks
  description: Orthostatic Hypotension Questionnaire (OHQ): The questionnaire is divided into 2 parts: Part I, Symptom Assessment (OHSA), consisted of 6 questions, each rat-ing the intensity of one characteristic symptom [ 1. Dizziness, lightheadedness, feeling faint, or feeling Iike you might black out; 2. Problems with vision (blurring, seeing spots, tunnel vision, etc.); 3. Generalized weakness; 4. Fatigue; 5. Trouble concentrating; 6. Head/neck dis-comfort] and Part Il, Daily Activity Scale (OHDAS), consisted of 4 questions that assessed the impact of NOH symptoms on daily activities.
  Items scored on an 11-point scale (0 to 10), with O indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. The composite OHQ score is calculated by averaging the OHSAS and the OHDAS.
  measure: Exercise capacity
  time frame: 12 weeks
  description: Six-minute walk test (performance and physiological responses)
  measure: Severity of pain and impact on functioning
  time frame: 12 weeks
  description: Brief Pain Inventory: Participants are asked to rate their current symptoms, their average experiences of pain, and the minimum and maximum intensities of their symptoms on scales that range from 0 to 10. A total pain severity score can be found by averaging these items or a single item can be treated as the primary outcome measure.
  measure: Type of pain
  time frame: 12 weeks
  description: Neuropathic pain DN4 Questionnaire: Items are scored based on a yes (1 point) /no (0 points) answer. This leads to a score range of 0-10 when the symptoms (range 0-7 points) as well as the signs (range 0-3 points) items are included.
  measure: Perceived quality of life
  time frame: 12 weeks
  description: Parkinson's Disease Questionnaire 8 items (PDQ-8, scored 0-32, higher score indicating the worst quality of life)
  measure: Lower-limb function
  time frame: 12 weeks
  description: Lower Extremity Functional Scale (LEFS, scored 0-32, higher score indicating less difficulty)
  measure: Mobility in the community
  time frame: 12 weeks
  description: Life-space mobility (French-Canadian version) (partial scores are summed to produce a composite score 0-120, higher score indicating more mobility)
  measure: Mobility
  time frame: 12 weeks
  description: Timed Up and Go
  measure: Balance
  time frame: 12 weeks
  description: Berg balance scale (scored 0-56, higher score indicating more balance)
  measure: Walking capacity
  time frame: 12 weeks
  description: 10-meter walk test
  measure: Lower-limb strength and power
  time frame: 12 weeks
  description: 5-repetition sit to stand test
  measure: Fine motor dexterity and coordination
  time frame: 12 weeks
  description: Purdue Pegboard Test
  measure: Cardiovascular health
  time frame: 12 weeks
  description: 24-hour ambulatory blood pressure monitoring (Mobil-O-Graph® 24hr ABPM) (systolic and diastolic blood pressure)
  measure: Sympathetic nervous innervation of the skin
  time frame: 12 weeks
  description: Electrodermal activity (Galvanic skin response) with PowerLab ADInstruments: Results are presented as the difference between the maximum of the electrodermal response (or of sweating, therefore of skin conductivity) and the minimum of the electrodermal response (delta values).
  measure: Autonomic modulation
  time frame: 12 weeks
  description: Heart rate variability (HRV) (supine 6 minutes and upright position 6 minutes)
  arm group label: Intervention group
  arm group type: Experimental
  description: Group of participants receiving the hybrid telerehabilitation intervention
  intervention type: Other
  intervention name: Hybrid telerehabilitation program
  description: The telerehabilitation program lasts 12 week (3 per week). The program includes aerobic, strength, coordination, balance, flexibility, and breathing exercises, in addition to educational components focused on disease management.
  This hybrid program incorporates both supervised and unsupervised sessions. A progressive approach from synchronous (supervised) to asynchronous (unsupervised) sessions is adopted.
  Each session is structured into 4 components: Warm-up; Muscle strengthening, coordination, and balance; Flexibility; and Breathing exercises.
  Participants are asked to maintain a log of their aerobic activity, recording details such as the type of activity, duration, and intensity. The aim is to align with the recommended aerobic physical activity guidelines (150 min/week). Weekly assessments are conducted to provide personalized guidance based on individual progress.
  Also, participants engage in weekly educational videos that cover a diverse range of PD-related topics.
  arm group label: Intervention group
  other name: OpenTera telerehabilitation
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Livia Pinheiro Carvalho, PhD
  role: Principal Investigator
  affiliation: Université de Sherbrooke
  last name: Livia Pinheiro Carvalho, PhD
  phone: 819 780-2220
  phone ext: 71095
  email: livia.pinheiro.carvalho@usherbrooke.ca
  last name: Leo Crepin, MSc(cand)
  email: leo.crepin@usherbrooke.ca
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Parkinson Disease
  mesh term: Primary Dysautonomias
  mesh term: Autonomic Nervous System Diseases