Feasibility and Dose Tolerability of HD-tDCS in Healthy Adults and Children With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      Transcranial direct current stimulation (tDCS) is a method which enables noninvasive
      electrical stimulation of the cortex via electrodes placed on the subject's skull. High
      definition tDCS (HD-tDCS) allows for precise generation of electrical fields over selected
      cortical areas using multiple electrodes. The purpose of this pilot trial is to study
      feasibility, tolerability, and safety of HD-tDCS administered daily for a total of 20
      sessions in healthy adults and 5-10 year old children with Down syndrome.

      PRIMARY OBJECTIVES Part I: To assess feasibility and tolerability of HD-tDCS, administered up
      to 5 days per week for a total of 20 sessions in healthy adult subjects; Part II: After
      review of the safety data for Part I is completed and reviewed by the Data Safety Monitoring
      Committee and IRB, Part II will be initiated. To assess feasibility and tolerability of
      HD-tDCS, administered up to 5 days per week for a total of 20 sessions in adult subjects with
      Down Syndrome.
    

Detailed description: 
      Transcranial direct current stimulation (tDCS) is a method which enables noninvasive
      electrical stimulation of the cortex via electrodes placed on the subject's skull. tDCS has
      been shown to improve motor learning, visuomotor coordination, probabilistic classification,
      boost memory in humans and was found to be well tolerated in children with early onset
      schizophrenia, continuous spike-wave in sleep (CSWS), refractory epilepsy and dystonia. The
      method has been approved for investigational purposes by the FDA. High definition tDCS
      (HD-tDCS) allows for precise generation of electrical fields over selected cortical areas
      using multiple electrodes. Positioning of the stimulating electrodes is determined with the
      help of MR brain images and appropriate modeling. The purpose of this pilot trial is to study
      feasibility, tolerability, and safety of HD-tDCS administered daily for a total of 20
      sessions.

      PRIMARY OBJECTIVES Part I: To assess feasibility and tolerability of HD-tDCS, administered up
      to 5 days per week for a total of 20 sessions in healthy adult subjects; Part I will be
      defined to be positive if 5 healthy adults are accrued within the study period (12 months)
      and at least 4 of 5 participants have successful completion. Tolerability will be measured as
      the proportion of subjects able to complete 20 sessions on the assigned treatment within 6
      weeks.

      Part II: After review of the safety data for Part I is completed and reviewed by the Data
      Safety Monitoring Committee and IRB, Part II will be initiated. To assess feasibility and
      tolerability of HD-tDCS, administered up to 5 days per week for a total of 20 sessions in
      pediatric subjects with Down Syndrome; Part II will be defined to be positive if 5 children
      with Down Syndrome are accrued within the study period (24 months) and at least 4 of 5
      participants have successful completion. Tolerability will be measured as the proportion of
      subjects able to complete 20 sessions on the assigned treatment within 6 weeks.

      SECONDARY OBJECTIVES Part I: - Collect pilot data on safety of HD-tDCS in healthy adults,
      where safety is defined by incidents of adverse events. Safety outcomes will include vital
      signs, physical/neurologic exam findings, weight, electrocardiograms and
      electroencephalograms.

      - Collect pilot data on feasibility of efficacy endpoints. These will include assessment of
      impact of HD-tDCS, administered up to 5 days per week for a total of 20 sessions, on EEG
      amplitudes and coherences in the lower (<8Hz) and higher (>9Hz) frequency ranges and
      coherences in the lower (<8Hz) and gamma (30-80 Hz) frequency ranges in healthy adults.

      Part II: - Collect pilot data on safety of HD-tDCS in children (5-10 years) with Down
      Syndrome, where safety is defined by incidents of adverse events. Procedures to monitor
      subject safety include vital sign measurements, physical/neurologic examinations,
      electrocardiograms and electroencephalograms. Clinically significant changes in the safety
      measures will be documented as adverse events.

      Collect pilot data on feasibility of efficacy endpoints. These will include assessment of
      impact of HD-tDCS, administered up to 5 days per week for a total of 20 sessions, on EEG
      amplitudes and coherences in the lower (<8Hz) and higher (>9Hz) frequency ranges and
      coherences in the lower (<8Hz) and gamma (30-80 Hz) frequency ranges in children with Down
      Syndrome.
    

Intervention name(s): High definition transcranial direct current stimulation
Intervention type(s): Device
Other intervention name(s): HD-tDCS
Intervention model: Single Group Assignment
Intervention model description: HD-tDCS (High definition transcranial direct current stimulation)
Masking: None (Open Label)
Primary purpose: Device Feasibility