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

NCT02481765 | Completed DMC

• 3 other identifiers: 2014-0262A535100SMPH/NEUROLOGY/NEUROLOGY
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Down Syndrome

Outcome Measures

Primary Outcomes (2)

• Feasibility and tolerability of HD-tDCS in healthy adult subjects

  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.

  One year

• Feasibility and tolerability of HD-tDCS in adults with Down syndrome

  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.

  Two years

Secondary Outcomes (4)

• Collect pilot data on safety of HD-tDCS in healthy adults

  One year

• Collect pilot data on feasibility of efficacy endpoints

  One year

• Collect pilot data on safety of HD-tDCS in adults with Down Syndrome

  Two years

• Collect pilot data on feasibility of efficacy endpoints.

  Two years

Study Arms (1)

Direct current Stimulation

EXPERIMENTAL

High definition transcranial direct current stimulation (HD-tDCS)

Device: High definition transcranial direct current stimulation

Interventions

High definition transcranial direct current stimulation DEVICE

Also known as: HD-tDCS

Direct current Stimulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

Department of Neurology, University of Wisconsin Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

• Turski CA, Kessler-Jones A, Chow C, Hermann B, Hsu D, Jones J, Seeger SK, Chappell R, Boly M, Ikonomidou C. Extended Multiple-Field High-Definition transcranial direct current stimulation (HD-tDCS) is well tolerated and safe in healthy adults. Restor Neurol Neurosci. 2017;35(6):631-642. doi: 10.3233/RNN-170757.

  PMID: 29172010 RESULT

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Hrissanthi Ikonomidou, MD PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: HD-tDCS (High definition transcranial direct current stimulation)

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 25, 2015
• Study Start: September 15, 2015
• Primary Completion: May 20, 2016
• Study Completion: May 20, 2016
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

US (1)