ADHDNCT01723319
A Double Blind Randomized Controlled Evaluation of the HBLPADD-coil Transcranial Magnetic Stimulation (TMS) Device - Efficacy and Safety In Subjects With ADHD.
A study testing HBLPADD coil deep TMS in people with ADHD, run by Shalvata Mental Health Center at 1 site in Israel.
Trial summary
Objectives:The purpose of the study is to explore the efficacy and safety of HBLPADD Coil deep brain TMS in subjects with ADHD. Patient Population: The intention is to treat 40 patients diagnosed with ADHD. The patients will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ADHD
- What is being tested?
- HBLPADD coil deep TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2012to May 2013
- 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 65 years
- All sexes
- No healthy volunteers
- 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.
- antipsychotic treatment with stabilizers; medications from the Benzodiazepines group are allowed, if need be,to a maximum dosage of 2 mg lorazepam.
- History of lack of tolerance to TMS.
- Axis 2 diagnosis according to the DSM IV.
- Substantial suicidal risk as judged by the treating psychiatrist or by an independent psychiatrist.
- Attempted suicide in the past year.
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- High and not controlled blood pressure.
- History of epilepsy, seizure, or hot spasm.
- History of epilepsy or seizure in first degree relatives.
- History of a significant head injury
- History of metal in the head (outside the mouth space).
- Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
- Use of hearing aids for hearing loss.
- History of frequent or severe headaches.
- History of drug or alcohol abuse during the last year.
- Inability to achieve satisfying level of communication with the subject.
- Participation in current clinical study or clinical study within 30 days prior to this study
- Patients declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.
- Women - Pregnancy or not using a reliable method of birth control.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Shalvata
Hod HaSharon
Yechiel levkovitz, MD, 972-9-7478644, ylevk@clalit.org.il
About this study
Objectives:The purpose of the study is to explore the efficacy and safety of HBLPADD Coil deep brain TMS in subjects with ADHD.
Patient Population: The intention is to treat 40 patients diagnosed with ADHD. The patients will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age.
Structure: The study is a randomized, prospective, 5 weeks, double blind study. Blinding: The treatment administrator and the study personnel and patients will be masked to the treatment being administrated.
The study group will receive active dTMS treatment and the control group will receive an inactive, sham treatment
- Conditions
- ADHD
- Being tested
- HBLPADD coil deep TMS, Sham
- Keywords
- ADHD, TMS, brain stimulation, clinical improvement
- 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.
HBLPADD coil deep TMSDevice
20 daily deep TMS treatment
ShamDevice
inactive treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | deep TMS treatment Receives: Device: HBLPADD coil deep TMS |
| 2 | Sham comparator | inactive treatment Receives: Device: Sham |
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: 5 weeks
Secondary outcomes (1)
clinical improvement as measured using Clinical global Impression (CGI).
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yechiel levkovitz, MD, Principal investigator, Shalvata Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723319
- Sponsor's protocol ID
- SH-0025-12
- Status last verified
- Nov 2012
- First submitted
- 5 Nov 2012
- Last updated
- 7 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomized Controlled Evaluation of the HBLPADD-coil Transcranial Magnetic Stimulation (TMS) Device - Efficacy and Safety In Subjects With ADHD.
- ClinicalTrials.gov ID
- NCT01723319
- Acronym / sponsor ID
- SH-0025-12
- Conditions
- ADHD
- Keywords
- ADHD, TMS, brain stimulation, clinical improvement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- May 2013 (estimated)
- First posted
- 7 Nov 2012 (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.
Objectives:The purpose of the study is to explore the efficacy and safety of HBLPADD Coil deep brain TMS in subjects with ADHD.
Patient Population: The intention is to treat 40 patients diagnosed with ADHD. The patients will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age.
Structure: The study is a randomized, prospective, 5 weeks, double blind study. Blinding: The treatment administrator and the study personnel and patients will be masked to the treatment being administrated.
The study group will receive active dTMS treatment and the control group will receive an inactive, sham treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: HBLPADD coil deep TMSdeep TMS treatment |
| 2 | Sham comparator | Device: Shaminactive treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not 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 (19 listed)
- Suffering from other diagnosis on axis 1.
- antipsychotic treatment with stabilizers; medications from the Benzodiazepines group are allowed, if need be,to a maximum dosage of 2 mg lorazepam.
- History of lack of tolerance to TMS.
- Axis 2 diagnosis according to the DSM IV.
- Substantial suicidal risk as judged by the treating psychiatrist or by an independent psychiatrist.
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 |
|---|---|---|
| HBLPADD coil deep TMS20 daily deep TMS treatment | Device | 1 |
| Shaminactive treatment | Device | 2 |
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: 5 weeks
1 secondary outcome
clinical improvement as measured using Clinical global Impression (CGI).
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2012.
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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.
yechiel levkovitz, MD principal investigator
Shalvata Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBLPADD coil deep TMS in people with ADHD, run by Shalvata Mental Health 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 19 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 7 Nov 2012. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yechiel Levkovitz, MD (972-9-7478644, ylevk@clalit.org.il), or a site near the patient. 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: 5 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 7 Nov 2012.