Adult Attention Deficit DisorderPhase 1BMSTNCT02206516
Feasibility of Transcranial Direct Current Stimulation (tDCS) in the Treatment of Adult Attention Deficit Disorder (ADD).
A Phase 1 study testing Transcranial Direct Current Stimulation in people with Adult Attention Deficit Disorder, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
This study aims at combining imaging techniques and clinical evaluations to assess clinical change as well as brain changes that occur as a result of brain stimulation in adult attention deficit disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult Attention Deficit Disorder
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2014to Sep 2018
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18-65(male and female)
- Diagnosed as suffering from Attention-Deficit Hyperactivity Disorder according to the DSM IV
- Patients taking medication for ADHD will give their consent to stop those medication 48 before entering the study and throughout the daily treatments.
- Gave informed consent for participation in the study
- If referred by the treating psychiatrist, he or she approves of the subjects participation in the study
Who cannot join
- Suffering from other diagnosis on axis 1
- History of drug or alcohol abuse during the last year
- Inability to achieve satisfying level of communication with the subject
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Combined Neuroimaging Techniques and Clinical Measures to Assess Feasibility of tDCS as an Intervention in Adult ADD.
This study aims at combining imaging techniques and clinical evaluations to assess clinical change as well as brain changes that occur as a result of brain stimulation in adult attention deficit disorder.
Read the detailed description
This study will use clinical measures and cognitive tasks covering 3 different functional domains during functional magnetic resonance imaging (fMRI), ElectroEncephaloGram (EEG) and Ultrasound tagged near infrared spectroscopy (UT-NIRS), to assess functional brain changes as a result of a treatment protocol with Transcaranial direct current stimulation (tDCS) in adults suffering from attention deficit disorder (ADD).
- Conditions
- Adult Attention Deficit Disorder
- Being tested
- Transcranial Direct Current Stimulation
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Also called neuroConn GmbH, Germany
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | Stimulation using tDCS will be administered daily, 5 days a week for 4 weeks. each session will last 22 minutes during which the anode electrode will be positioned over the right Inferior Frontal Gyrus (IFG) and the Katode electrode over the right Orbito Frontal Gyrus (OFG). Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy will be examined by the change in the CAARS questionnaire from the baseline visit to the determination visit in the treatment group compared to the control group.
Measured: 6 weeks
Secondary outcomes (1)
changes in functional activity after 4 weeks of tDCS treatment during response inhibition
ROI analysis of right Inferior frontal cortex will be measured during response inhibition in the Go/Nogo task at the end of the 4 weeks of treatment and will be compared to baseline measures.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2017
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Attention Deficit DisorderStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- ElMindA Ltd, Brainsway, Ornim Medical Ltd.
- Responsible party
- Sponsor
- Investigators
- Talma Hendler, MD, PhD, Principal investigator, TASMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206516
- Sponsor's protocol ID
- 0214-14
- Acronym
- BMST
- Status last verified
- Mar 2018
- First submitted
- 28 Jul 2014
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Combined Neuroimaging Techniques and Clinical Measures to Assess Feasibility of tDCS as an Intervention in Adult ADD.
- ClinicalTrials.gov ID
- NCT02206516
- Acronym / sponsor ID
- BMST / 0214-14
- Conditions
- Adult Attention Deficit Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- ElMindA Ltd, Brainsway, Ornim Medical Ltd.
- Study start
- Jul 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2018 (estimated)
- First posted
- 1 Aug 2014 (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.
This study aims at combining imaging techniques and clinical evaluations to assess clinical change as well as brain changes that occur as a result of brain stimulation in adult attention deficit disorder.
Detailed description
This study will use clinical measures and cognitive tasks covering 3 different functional domains during functional magnetic resonance imaging (fMRI), ElectroEncephaloGram (EEG) and Ultrasound tagged near infrared spectroscopy (UT-NIRS), to assess functional brain changes as a result of a treatment protocol with Transcaranial direct current stimulation (tDCS) in adults suffering from attention deficit disorder (ADD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Device: Transcranial Direct Current StimulationStimulation using tDCS will be administered daily, 5 days a week for 4 weeks. each session will last 22 minutes during which the anode electrode will be positioned over the right Inferior Frontal Gyrus (IFG) and the Katode electrode over the right Orbito Frontal Gyrus (OFG). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients between the ages of 18-65(male and female)
- Diagnosed as suffering from Attention-Deficit Hyperactivity Disorder according to the DSM IV
- Patients taking medication for ADHD will give their consent to stop those medication 48 before entering the study and throughout the daily treatments.
- Gave informed consent for participation in the study
- If referred by the treating psychiatrist, he or she approves of the subjects participation in the study
Key exclusion criteria (3 listed)
- Suffering from other diagnosis on axis 1
- History of drug or alcohol abuse during the last year
- Inability to achieve satisfying level of communication with the subject
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 |
|---|---|---|
| Transcranial Direct Current StimulationAlso: neuroConn GmbH, Germany | Device | patients |
Primary outcome
Efficacy will be examined by the change in the CAARS questionnaire from the baseline visit to the determination visit in the treatment group compared to the control group.
Time frame: 6 weeks
1 secondary outcome
changes in functional activity after 4 weeks of tDCS treatment during response inhibition
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
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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.
Talma Hendler, MD, PhD principal investigator
TASMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transcranial Direct Current Stimulation in people with Adult Attention Deficit Disorder, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Mar 2018. 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 Israel. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Efficacy will be examined by the change in the CAARS questionnaire from the baseline visit to the determination visit in the treatment group compared to the control group. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2018.