Attention Deficit/Hyperactivity DisorderNCT01618110
Transcranial Magnetic Stimulation in Treatment of Attention Deficit/Hyperactivity Disorders
A study testing Transcranial Magnetic Stimulation (Magstim, Rapid) in people with Attention Deficit/Hyperactivity Disorder, run by Shalvata Mental Health Center at 1 site in Israel.
Trial summary
ADHD is one of the most common psychiatric disorders. While most of the attention is directed towards youth, 60% continue to suffer symptoms into adult life. Current treatment is effective, but 30% suffer side effects that lowers QOL, and 20% are non-responders. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder
- What is being tested?
- Transcranial Magnetic Stimulation (Magstim, Rapid)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2012to Jul 2014
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50
- Established diagnosis of ADHD
- No C/I for TMS
- Has signed an informed consent form
Who cannot join
- Major Psychiatric disorders (Psychotic or Affective)
- Active use of drugs (4 weeks prior to participation)
- Neurologic disorder such as Epilepsy.
- No use of stimulants during the previous 7 days
Trial locations and contacts
1 site in 1 country.
Israel1 site
Shalvata MHC
Hod HaSharon
Aviv Segev, MD, 972-9-7478-644, aviv.segev@clalit.org.il
Yuval Bloch, MD
About this study
Official title: Transcranial Magnetic Stimulation of the Pre-Frontal Cortex in the Treatment of Attention Deficit/Hyperactivity Disorders: A Randomized, Controlled, Double Blind Study.
- ADHD is one of the most common psychiatric disorders.
- While most of the attention is directed towards youth, 60% continue to suffer symptoms into adult life.
- Current treatment is effective, but 30% suffer side effects that lowers QOL, and 20% are non-responders.
- Known mechanism of pathophysiology includes hypoactive dopaminergic system, especially at right PFC.
- It is this study hypothesis that by stimulating the right PFC by TMS, it will be possible to alleviate ADHD symptoms.
- A 10 sessions of treatment will by applied on a randomly allocated group of patients, diagnosed with ADHD, in a 2:1 ratio: The first group will receive an actual TMS treatment, and the second group will receive a sham treatment.
- Improvement of objective and subjective ADHD scale will be examined.
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Being tested
- Transcranial Magnetic Stimulation (Magstim, Rapid), Placebo Treatment
- Keywords
- ADHD, Attention Deficit/Hyperactivity Disorder, TMS, Transcranial Magnetic 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 Magnetic Stimulation (Magstim, Rapid)Device
Also called Magstim, Rapid, Transcranial Magnetic Stimulation
Superficial rTMS, directed at right PFC, power of 100% of MT, 10Hz for 4 seconds, intervals of 30 seconds, 42 trains.
Placebo TreatmentOther
Also called Placebo, Sham
Sham coil (minimal magnetic field, same noise and feeling)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | Not described Receives: Device: Transcranial Magnetic Stimulation (Magstim, Rapid) |
| Sham group | Sham comparator | Sham TMS coil (same noise, minimal magnetic field) Receives: Other: Placebo Treatment |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit/Hyperactivity DisorderStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuval Bloch, MD, Principal investigator, Shalvata MHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618110
- Sponsor's protocol ID
- SH-12-0012
- Status last verified
- Jun 2012
- First submitted
- 10 Jun 2012
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation of the Pre-Frontal Cortex in the Treatment of Attention Deficit/Hyperactivity Disorders: A Randomized, Controlled, Double Blind Study.
- ClinicalTrials.gov ID
- NCT01618110
- Acronym / sponsor ID
- SH-12-0012
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Keywords
- ADHD, Attention Deficit/Hyperactivity Disorder, TMS, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 13 Jun 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.
- ADHD is one of the most common psychiatric disorders.
- While most of the attention is directed towards youth, 60% continue to suffer symptoms into adult life.
- Current treatment is effective, but 30% suffer side effects that lowers QOL, and 20% are non-responders.
- Known mechanism of pathophysiology includes hypoactive dopaminergic system, especially at right PFC.
- It is this study hypothesis that by stimulating the right PFC by TMS, it will be possible to alleviate ADHD symptoms.
- A 10 sessions of treatment will by applied on a randomly allocated group of patients, diagnosed with ADHD, in a 2:1 ratio: The first group will receive an actual TMS treatment, and the second group will receive a sham treatment.
- Improvement of objective and subjective ADHD scale will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Device: Transcranial Magnetic Stimulation (Magstim, Rapid) |
| Sham group | Sham comparator | Other: Placebo TreatmentSham TMS coil (same noise, minimal magnetic field) |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-50
- Established diagnosis of ADHD
- No C/I for TMS
- Has signed an informed consent form
Key exclusion criteria (4 listed)
- Major Psychiatric disorders (Psychotic or Affective)
- Active use of drugs (4 weeks prior to participation)
- Neurologic disorder such as Epilepsy.
- No use of stimulants during the previous 7 days
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 Magnetic Stimulation (Magstim, Rapid)Also: Magstim, Rapid, Transcranial Magnetic StimulationSuperficial rTMS, directed at right PFC, power of 100% of MT, 10Hz for 4 seconds, intervals of 30 seconds, 42 trains. | Device | Treatment Group |
| Placebo TreatmentAlso: Placebo, ShamSham coil (minimal magnetic field, same noise and feeling) | Other | Sham group |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 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.
Yuval Bloch, MD principal investigator
Shalvata MHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (Magstim, Rapid) in people with Attention Deficit/Hyperactivity Disorder, 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 4 inclusion and 4 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 19 Jun 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 Aviv Segev, MD (972-9-7478-644, aviv.segev@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 19 Jun 2012.