ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    ikonomidou
Previous Study | Return to List | Next Study

Feasibility and Dose Tolerability of HD-tDCS in Healthy Adults and Adults With Down Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02481765
Recruitment Status : Unknown
Verified May 2016 by University of Wisconsin, Madison.
Recruitment status was:  Active, not recruiting
First Posted : June 25, 2015
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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 adults 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.


Condition or disease Intervention/treatment Phase
Down Syndrome Device: High definition transcranial direct current stimulation Phase 1

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 adult subjects with Down Syndrome; Part II will be defined to be positive if 5 adults with Down Syndrome 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.

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 adults with Down Syndrome, 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 adults with Down Syndrome.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Phase I Trial of the Feasibility and Dose Tolerability of High Definition Transcranial Direct Current Stimulation in Healthy Adults and Adults With Down Syndrome
Study Start Date : June 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Arm Intervention/treatment
Experimental: Direct current Stimulation
High definition transcranial direct current stimulation (HD-tDCS)
Device: High definition transcranial direct current stimulation
Other Name: HD-tDCS




Primary Outcome Measures :
  1. Feasibility and tolerability of HD-tDCS in healthy adult subjects [ Time Frame: One year ]
    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 4 of 5 participants (80%) have successful completion.

  2. Feasibility and tolerability of HD-tDCS in adults with Down syndrome [ Time Frame: Two years ]
    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; Part II will be defined to be positive if 5 adults with Down Syndrome are accrued within the study period (12 months) and at least 4 of 5 participants (80%) have successful completion.


Secondary Outcome Measures :
  1. Collect pilot data on safety of HD-tDCS in healthy adults [ Time Frame: One year ]
    Collect pilot data on safety of HD-tDCS in healthy adults, where safety is defined by incidence of adverse events.

  2. Collect pilot data on feasibility of efficacy endpoints [ Time Frame: One year ]
    - 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 healthy adults

  3. Collect pilot data on safety of HD-tDCS in adults with Down Syndrome [ Time Frame: Two years ]
    Collect pilot data on safety of HD-tDCS in adults with Down Syndrome, where safety is defined by incidence of adverse events.

  4. Collect pilot data on feasibility of efficacy endpoints. [ Time Frame: Two years ]
    - 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

PART I

Inclusion Criteria:

  • Adult aged > 18 years and ≤ 45 years
  • Healthy Adult subjects have the ability to consent for themselves.

No previous or current medical history of epilepsy, neurologic, heart, endocrinologic, renal, chronic infectious, metabolic, psychiatric disease or cancer

  • Normal physical examination
  • Normal neurologic examination
  • Normal EKG
  • Normal EEG
  • IQ above 80. We will only include individuals with college education to assure that IQ requirements are met.

Exclusion Criteria:

  • Previous or current medical history of epilepsy, neurologic, heart, endocrinologic, renal, chronic infectious, metabolic, psychiatric disease or cancer
  • Healthy adult subjects will be excluded from the study if the subject is not suitable for study participation due to other reasons, at the discretion of the PI.

PART II

Inclusion criteria

  • Adult aged > 18 years and ≤ 45 years
  • Genetically confirmed Trisomy 21

Exclusion criteria

  • Cardiac, hematologic, oncologic comorbidities that require intensive medical treatment. Intensive medical treatment means that the subject is undergoing chemotherapy for a hematologic/oncologic condition, is carrying a pacemaker or has been diagnosed with a cardiac anomaly which causes cardiac insufficiency not compensated with medications.
  • Active epilepsy, history of epilepsy, history of seizures or with epileptiform discharges on screening baseline EEG.
  • Anticipated inability of the subject to comply with the rigors of the protocol as outlined in the consent form.
  • Behavioral problems of sufficient magnitude to preclude participation in the study. These include anxiety, obsessive compulsive behaviors, attention problems, agitation, oppositional behavior. These behavioral problems will be assessed during the first visit and the PI will make decision to exclude subjects which she considers will not be able to complete the study.
  • The subject is legally blind (vision acuity <20/200 not correctable with lenses, as determined be a certified optometrist or an ophthalmologist).
  • The subject is severely hearing impaired (Hearing level >71 dB, as measured with a standard audiometer at frequencies between 8 and 20 kHz).
  • The subject is not suitable for study participation due to other reasons, at the discretion of the PI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481765


Locations
United States, Wisconsin
Department of Neurology, University of Wisconsin Madison
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Hrissanthi Ikonomidou, MD PhD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02481765     History of Changes
Other Study ID Numbers: 2014-0262
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Syndrome
Down Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn