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

Completed · Not applicable

Conditions studied: Down Syndrome

In brief

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.

Key facts

Study ID

NCT02481765

Run by

University of Wisconsin, Madison

People needed

5

Starts

2015-09-15

Expected to finish

2016-05-20

Last updated by the study team

2020-02-11

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

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
• 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.

Where it is running

• Department of Neurology, University of Wisconsin Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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