Down SyndromeNCT02481765
Feasibility and Dose Tolerability of HD-tDCS in Healthy Adults and Children With Down Syndrome
A study testing High definition transcranial direct current stimulation in people with Down Syndrome, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- High definition transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2015to 20 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- Normal EEG
- IQ above 80. We will only include individuals with college education to assure that IQ requirements are met.
- Adult aged > 18 years and ≤ 45 years
- Genetically confirmed Trisomy 21
Who cannot join
- 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
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Neurology, University of Wisconsin Madison
Madison, Wisconsin, 53705
About this study
Official title: Phase I Trial of the Feasibility and Dose Tolerability of High Definition Transcranial Direct Current Stimulation in Healthy Adults and Children With Down Syndrome
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.
Read the 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.
- Conditions
- Down Syndrome
- Being tested
- High definition transcranial direct current stimulation
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High definition transcranial direct current stimulationDevice
Also called HD-tDCS
| Study group | Role | What they receive |
|---|---|---|
| Direct current Stimulation | Experimental | High definition transcranial direct current stimulation (HD-tDCS) Receives: Device: High definition transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Two years
Secondary outcomes (4)
Collect pilot data on safety of HD-tDCS in healthy adults
Collect pilot data on safety of HD-tDCS in healthy adults, where safety is defined by incidence of adverse events.
Measured: One year
Collect pilot data on feasibility of efficacy endpoints
- 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
Measured: One year
Collect pilot data on safety of HD-tDCS in adults with Down Syndrome
Collect pilot data on safety of HD-tDCS in adults with Down Syndrome, where safety is defined by incidence of adverse events.
Measured: Two years
Collect pilot data on feasibility of efficacy endpoints.
- 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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study start15 Sep 2015
- Primary completion20 May 2016
- Study completion20 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- HD-tDCS (High definition transcranial direct current stimulation)
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hrissanthi Ikonomidou, MD PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481765
- Sponsor's protocol ID
- 2014-0262
- Other IDs
- A535100, SMPH/NEUROLOGY/NEUROLOGY
- Status last verified
- Feb 2020
- First submitted
- 16 Jun 2015
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29172010
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of the Feasibility and Dose Tolerability of High Definition Transcranial Direct Current Stimulation in Healthy Adults and Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT02481765
- Acronym / sponsor ID
- 2014-0262
- Conditions
- Down Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- 20 May 2016 (actual)
- Study completion
- 20 May 2016 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- HD-tDCS (High definition transcranial direct current stimulation)
| Arm | Type | Receives |
|---|---|---|
| Direct current Stimulation | Experimental | Device: High definition transcranial direct current stimulationHigh definition transcranial direct current stimulation (HD-tDCS) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High definition transcranial direct current stimulationAlso: HD-tDCS | Device | Direct current Stimulation |
Primary outcome
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.
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.
4 secondary outcomes
Collect pilot data on safety of HD-tDCS in healthy adults
Time frame: One year
Collect pilot data on feasibility of efficacy endpoints
Time frame: One year
Collect pilot data on safety of HD-tDCS in adults with Down Syndrome
Time frame: Two years
Collect pilot data on feasibility of efficacy endpoints.
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Results publication: PubMed 29172010Turski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hrissanthi Ikonomidou, MD PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High definition transcranial direct current stimulation in people with Down Syndrome, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and tolerability of HD-tDCS in healthy adult subjects (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02481765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.