<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/NCT03837795</url>
  </required_header>
  <id_info>
    <org_study_id>1710.18</org_study_id>
    <nct_id>NCT03837795</nct_id>
  </id_info>
  <brief_title>Examining the Efficiency of Neurofeedback Therapy on Adults With Sensory Over Responsivity</brief_title>
  <official_title>The Efficiency of Neurofeedback Therapy for Enhancing Participation in Occupations, Decreasing Pain Sensitivity, Improving Life Satisfaction and Brain Neural Activity in Adults With Sensory Over Responsivity - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel Aviv University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel Aviv 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>
      Sensory Over-Responsivity (SOR) is characterized by a disruption in regulating sensory&#xD;
      stimuli and can significantly impact pain perception and restrict daily participation and&#xD;
      quality of life. Altered neurophysiological processes in SOR are documented, revealing&#xD;
      reduced electroencephalogram at rest and P300 amplitudes, the latter tested through&#xD;
      event-related potentials (ERP). Both may explain the failure to regulate incoming sensory&#xD;
      stimuli. Neurofeedback (NF) therapy, a remedial treatment approach, aims at self-regulating&#xD;
      the brain's neural activity and has proven its efficiency in treating comorbid SMD syndromes.&#xD;
&#xD;
      Our study aims to investigate NF therapy efficiency in decreasing pain sensitivity, enhancing&#xD;
      auditory ERP components of P300, increasing the power of the alpha band, life-satisfaction&#xD;
      and Goal Attainment Scaling (GAS) scores in adults with SOR.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this serial experimental research design, 10 individuals with SOR aged 21-45 years will&#xD;
      participate. A medical and demographic questionnaire and the Sensory Responsiveness&#xD;
      Questionnaire-Intensity Scale (SRQ-IS) will be applied to screen for participation&#xD;
      eligibility. Outcome measures will be conducted at 4-time points (1. baseline- 3 weeks&#xD;
      pre-treatment; 2. before the first treatment session; 3. after the last treatment session;&#xD;
      and 4. a month post-treatment) applying: The Goal Attainment Scaling (GAS), the P300&#xD;
      component using a neurophysiological assessment of the 'Oddball paradigm', the alpha power&#xD;
      using electroencephalogram resting state, and electronic versions of the Satisfaction with&#xD;
      Life Scale, the World Health Organization Disability Assessment Schedule, and the Pain&#xD;
      Sensitivity Questionnaire. Sixteen individually therapy sessions of 45 minutes each, twice a&#xD;
      week, will be held at the same time of day.&#xD;
&#xD;
      Repeated measures ANOVA or a non-parametric equivalent will be used to analyze the dependent&#xD;
      variables measures change over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">October 15, 2020</completion_date>
  <primary_completion_date type="Actual">October 15, 2020</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>it is a serial experimental research design, which includes 10 individuals with sensory over responsivity aged 21-45 years will participate</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The researcher that will perform the measurement assessments will differ from the one that will provide the therapy sessions.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The Satisfaction with Life Scale (SWLS)</measure>
    <time_frame>assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session</time_frame>
    <description>assesses global life satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Goal Attainment Scaling (GAS)</measure>
    <time_frame>assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session</time_frame>
    <description>a standardized therapeutic method used to evaluate the participants' progress toward their functional goals</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The World Health Organization Disability Assessment Schedule (WHODAS-2.0)</measure>
    <time_frame>assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session</time_frame>
    <description>To evaluate participants' participation level in the last month</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Sensitivity Questionnaire (PSQ)</measure>
    <time_frame>3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment</time_frame>
    <description>a standardized self-report questionnaire assessing daily pain sensitivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electroencephalogram (EEG) Resting State</measure>
    <time_frame>3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment</time_frame>
    <description>To measure alpha band (8-12Hz) power</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Auditory Evoked Related Potentials (AERP)</measure>
    <time_frame>3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment</time_frame>
    <description>Change from Baseline to 28 days after the last treatment session: An EEG method will be used to evaluate the brain responses to auditory stimulus.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Sensory Modulation Disorder</condition>
  <condition>Sensory Over-Responsivity</condition>
  <arm_group>
    <arm_group_label>Neurofeedback therapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neurofeedback treatment</intervention_name>
    <description>A treatment that developed to train adults with sensory modulation disorder by applying EEG (Curry 7 EEG system, Neuroscan-Compumedics). This treatment will aim to normalize the Alpha power (amplitude).</description>
    <arm_group_label>Neurofeedback therapy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Having SOR indicated by a score higher than 2.39 on the Sensory Responsiveness&#xD;
             Questionnaire-Aversive scale.&#xD;
&#xD;
          2. free of analgesic medicines for no less than 24 hours before the sessions.&#xD;
&#xD;
          3. independent functioning in the community.&#xD;
&#xD;
          4. fluency in understanding and reading Hebrew&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. metabolic, psychiatric, neurological, or neuro-developmental, but ADHD diagnosis&#xD;
&#xD;
          2. acute or chronic pain.&#xD;
&#xD;
          3. regular intake of neurological, psychiatric and analgesic medicines.&#xD;
&#xD;
          4. participating in other therapies (i.e., cognitive therapies) at present.&#xD;
&#xD;
          5. substance abuse.&#xD;
&#xD;
          6. pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dr. Tami Bar-Shalita</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>April 6, 2021</last_update_submitted>
  <last_update_submitted_qc>April 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tel Aviv University</investigator_affiliation>
    <investigator_full_name>Tami Bar-Shalita</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Neurofeedback</keyword>
  <keyword>Sensory Modulation Disorder</keyword>
  <keyword>Sensory Over-Responsivity</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03837795
org study id: 1710.18
nct id: NCT03837795
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sensory Over-Responsivity (SOR) is characterized by a disruption in regulating sensory
      stimuli and can significantly impact pain perception and restrict daily participation and
      quality of life. Altered neurophysiological processes in SOR are documented, revealing
      reduced electroencephalogram at rest and P300 amplitudes, the latter tested through
      event-related potentials (ERP). Both may explain the failure to regulate incoming sensory
      stimuli. Neurofeedback (NF) therapy, a remedial treatment approach, aims at self-regulating
      the brain's neural activity and has proven its efficiency in treating comorbid SMD syndromes.

      Our study aims to investigate NF therapy efficiency in decreasing pain sensitivity, enhancing
      auditory ERP components of P300, increasing the power of the alpha band, life-satisfaction
      and Goal Attainment Scaling (GAS) scores in adults with SOR.
In this serial experimental research design, 10 individuals with SOR aged 21-45 years will
      participate. A medical and demographic questionnaire and the Sensory Responsiveness
      Questionnaire-Intensity Scale (SRQ-IS) will be applied to screen for participation
      eligibility. Outcome measures will be conducted at 4-time points (1. baseline- 3 weeks
      pre-treatment; 2. before the first treatment session; 3. after the last treatment session;
      and 4. a month post-treatment) applying: The Goal Attainment Scaling (GAS), the P300
      component using a neurophysiological assessment of the 'Oddball paradigm', the alpha power
      using electroencephalogram resting state, and electronic versions of the Satisfaction with
      Life Scale, the World Health Organization Disability Assessment Schedule, and the Pain
      Sensitivity Questionnaire. Sixteen individually therapy sessions of 45 minutes each, twice a
      week, will be held at the same time of day.

      Repeated measures ANOVA or a non-parametric equivalent will be used to analyze the dependent
      variables measures change over time.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: it is a serial experimental research design, which includes 10 individuals with sensory over responsivity aged 21-45 years will participate
primary purpose: Treatment
masking: None (Open Label)
masking description: The researcher that will perform the measurement assessments will differ from the one that will provide the therapy sessions.
measure: The Satisfaction with Life Scale (SWLS)
time frame: assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session
description: assesses global life satisfaction
measure: Goal Attainment Scaling (GAS)
time frame: assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session
description: a standardized therapeutic method used to evaluate the participants' progress toward their functional goals
measure: The World Health Organization Disability Assessment Schedule (WHODAS-2.0)
time frame: assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session
description: To evaluate participants' participation level in the last month
measure: Pain Sensitivity Questionnaire (PSQ)
time frame: 3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment
description: a standardized self-report questionnaire assessing daily pain sensitivity
measure: Electroencephalogram (EEG) Resting State
time frame: 3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment
description: To measure alpha band (8-12Hz) power
measure: Auditory Evoked Related Potentials (AERP)
time frame: 3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment
description: Change from Baseline to 28 days after the last treatment session: An EEG method will be used to evaluate the brain responses to auditory stimulus.
arm group label: Neurofeedback therapy group
arm group type: Experimental
intervention type: Device
intervention name: Neurofeedback treatment
description: A treatment that developed to train adults with sensory modulation disorder by applying EEG (Curry 7 EEG system, Neuroscan-Compumedics). This treatment will aim to normalize the Alpha power (amplitude).
arm group label: Neurofeedback therapy group
criteria: 
gender: All
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Tel Aviv University
investigator full name: Tami Bar-Shalita
investigator title: Principal Investigator