Attention Deficit Disorder PatientsNCT01737476
Trial to Evaluate the Efficacy of the HLPFC Coil Deep Transcranial Magnetic Stimulation System in Treating Attention Deficit and Hyperactivity Disorder (ADHD) in Adults
A study testing Transcranial Magnetic Stimulation. PFC in people with Attention Deficit Disorder Patients, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The aim of the study is to investigate the efficacy of trans-cranial magnetic stimulation in treating attention deficit disorder in adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Attention Deficit Disorder Patients
- What is being tested?
- Transcranial Magnetic Stimulation. PFC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2012to Aug 2015
- 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
- 18-65 years
- ADD/ADHD
Who cannot join
- any DSM-IV psychiatric disorder except ADD/ADHD
- use of psychoactive medications
- Epilepsy
- brain injury
Trial locations and contacts
1 site in 1 country.
Israel1 site
Ben-Gurion University
Beersheba
Hadar Shalev, MD, 97286400353, shalev@bgu.ac.il
About this study
The aim of the study is to investigate the efficacy of trans-cranial magnetic stimulation in treating attention deficit disorder in adults.
- Conditions
- Attention Deficit Disorder Patients
- Being tested
- Transcranial Magnetic Stimulation. PFC
- Keywords
- age 18-65
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation. PFCProcedure or surgery
Also called Stimulator: Magstim rapid2. The Magstim Company Limited, Spring gardens, Whitland, Carmarthenshire, SA34 OHR, UK., Coil: HLPFC. Brainsway Ltd. 19 hartum St. Bynet Building, Har Hatzofim, Jerusalem, Israel.
| Study group | Role | What they receive |
|---|---|---|
| control | Sham comparator | control-sham Receives: Procedure: Transcranial Magnetic Stimulation. PFC |
| Deep TMS PFC Lt | Active comparator | Deep TMS PFC left Receives: Procedure: Transcranial Magnetic Stimulation. PFC |
| DEEP TMS PFC Rt | Active comparator | DEEP TMS PFC Rt Receives: Procedure: Transcranial Magnetic Stimulation. PFC |
| Superficial TMS PFC Lt | Active comparator | Superficial TMS PFC Lt Receives: Procedure: Transcranial Magnetic Stimulation. PFC |
| superficial TMS PFC Rt | Active comparator | superficial TMS PFC Rt Receives: Procedure: Transcranial Magnetic Stimulation. PFC |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2015 (estimated)
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 Attention Deficit Disorder PatientsStudies 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, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737476
- Sponsor's protocol ID
- sor010912ctil
- Status last verified
- Nov 2012
- First submitted
- 20 Sep 2012
- Last updated
- 29 Nov 2012
- Results posted
- No
Publications
Hadas I, Hadar A, Lazarovits A, Daskalakis ZJ, Zangen A. Right prefrontal activation predicts ADHD and its severity: A TMS-EEG study in young adults. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Dec 20;111:110340. doi: 10.1016/j.pnpbp.2021.110340. Epub 2021 May 3.
PubMed 33957168
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Evaluate the Efficacy of the HLPFC Coil Deep Transcranial Magnetic Stimulation System in Treating Attention Deficit and Hyperactivity Disorder (ADHD) in Adults
- ClinicalTrials.gov ID
- NCT01737476
- Acronym / sponsor ID
- sor010912ctil
- Conditions
- Attention Deficit Disorder Patients
- Keywords
- age 18-65
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Aug 2015 (estimated)
- First posted
- 29 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.
The aim of the study is to investigate the efficacy of trans-cranial magnetic stimulation in treating attention deficit disorder in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| control | Sham comparator | Procedure: Transcranial Magnetic Stimulation. PFCcontrol-sham |
| Deep TMS PFC Lt | Active comparator | Procedure: Transcranial Magnetic Stimulation. PFCDeep TMS PFC left |
| DEEP TMS PFC Rt | Active comparator | Procedure: Transcranial Magnetic Stimulation. PFCDEEP TMS PFC Rt |
| Superficial TMS PFC Lt | Active comparator | Procedure: Transcranial Magnetic Stimulation. PFCSuperficial TMS PFC Lt |
| superficial TMS PFC Rt | Active comparator | Procedure: Transcranial Magnetic Stimulation. PFCsuperficial TMS PFC Rt |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years
- ADD/ADHD
Key exclusion criteria (4 listed)
- any DSM-IV psychiatric disorder except ADD/ADHD
- use of psychoactive medications
- Epilepsy
- brain injury
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. PFCAlso: Stimulator: Magstim rapid2. The Magstim Company Limited, Spring gardens, Whitland, Carmarthenshire, SA34 OHR, UK., Coil: HLPFC. Brainsway Ltd. 19 hartum St. Bynet Building, Har Hatzofim, Jerusalem, Israel. | Procedure or surgery | DEEP TMS PFC Rt, Deep TMS PFC Lt, Superficial TMS PFC Lt, control, superficial TMS PFC Rt |
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 29 Nov 2012.
- Derived from this study: PubMed 33957168Hadas I, Hadar A, Lazarovits A, Daskalakis ZJ, Zangen A. Right prefrontal activation predicts ADHD and its severity: A TMS-EEG study in young adults. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Dec 20;111:110340. doi: 10.1016/j.pnpbp.2021.110340. Epub 2021 May 3.
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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.
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. PFC in people with Attention Deficit Disorder Patients, run by Soroka University 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 2 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 29 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 Hadar Shalev, MD (97286400353, shalev@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01737476, 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 29 Nov 2012.