Attention Deficit DisorderNCT06030024
Efficacy of Repetitive Transcranial Magnetic Stimulation in Adult Attention Deficit Disorder
A study testing repetitive Transcranial Magnetic Stimulation in people with Attention Deficit Disorder and ADHD, run by University of Tehran at 1 site in Iran.
Trial summary
The purpose of the current open-lable study was to use low-frequency repetitive transcranial magnetic stimulation (rTMS) to improve the attention deficits in a sample of adult patients suffering from attention deficit disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Attention Deficit Disorder, ADHD
- What is being tested?
- repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIran
- Study dates
- 1 Sep 2021to 1 Mar 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Normal intelligence level (>90)
- Diagnosis of ADD by a psychiatrist using the ADHD-RS-IV with Adult Prompts
Who cannot join
- Scores of 21 or more on BDI and/or BAI
- History of head trauma
- History of a major psychological or neurological condition
- Presence of metal in the head
- History of seizures
- Serious cardiovascular disease
- Use of medications with an impact on cognitive functions during the treatment window (patients with a constant and stable dose were included)
- Recent use of alcohol or substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-lable Investigation of the Effect of rTMS on Attention in an Adult Sample Suffering From ADD
The purpose of the current open-lable study was to use low-frequency repetitive transcranial magnetic stimulation (rTMS) to improve the attention deficits in a sample of adult patients suffering from attention deficit disorder. Participants received 10 sessions of rTMS over Fz (located using the EEG 10-20 international system) and underwent assessments of their attentional capacity using the gradCPT task in an fMRI scanner, before and after the intervention. Other behavioral assessments of their attention symptoms have also been conducted.
- Conditions
- Attention Deficit Disorder, ADHD
- Being tested
- repetitive Transcranial Magnetic Stimulation
- Keywords
- rTMS, ADHD, ADD, fMRI
- 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.
repetitive Transcranial Magnetic StimulationDevice
Magnetic pulses delivered to the Fz area of the brain in a low frequency (1 Hz) manner.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Experimental | Participants in this one and only arm in the current study received active repetitive transcranial magnetic stimulation. Receives: Device: repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance
Shortened version (4 min) of the continuous go/no-go task: gradual-onset continuous performance task (gradCPT)
Measured: Up to 10 days, i.e., before and after the completion of the 10 sessions of rTMS
Secondary outcomes (2)
Change in self-report attention scores
The 6-item ASRS-V1.1 Adult ADHD Self-Report
Measured: Baseline, after 5 days of stimulation, after 10 days of stimulation; Range= 0-6; Higher scores represent worse outcome
Change in investigator-rated attention scores
Investigator-Rated Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV (I-ADHD RS-IV) with adult prompts
Measured: Baseline, after 5 days of stimulation, after 10 days of stimulation; Range:0 - 54; Higher scores represent worse outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Sep 2021
- Primary completion1 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tehran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, reza kazemi, University of Tehran
- Investigators
- Reza Rostami, M.D, Study director, University of TehranFatemeh Soltani, MSc, Principal investigator, University of Tehran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030024
- Sponsor's protocol ID
- Attention
- Status last verified
- Sep 2023
- First submitted
- 1 Sep 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-lable Investigation of the Effect of rTMS on Attention in an Adult Sample Suffering From ADD
- ClinicalTrials.gov ID
- NCT06030024
- Acronym / sponsor ID
- Attention
- Conditions
- Attention Deficit Disorder, ADHD
- Keywords
- rTMS, ADHD, ADD, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of TehranUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 8 Sep 2023 (actual)
- 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 purpose of the current open-lable study was to use low-frequency repetitive transcranial magnetic stimulation (rTMS) to improve the attention deficits in a sample of adult patients suffering from attention deficit disorder. Participants received 10 sessions of rTMS over Fz (located using the EEG 10-20 international system) and underwent assessments of their attentional capacity using the gradCPT task in an fMRI scanner, before and after the intervention. Other behavioral assessments of their attention symptoms have also been conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Experimental | Device: repetitive Transcranial Magnetic StimulationParticipants in this one and only arm in the current study received active repetitive transcranial magnetic stimulation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normal intelligence level (>90)
- Diagnosis of ADD by a psychiatrist using the ADHD-RS-IV with Adult Prompts
Key exclusion criteria (8 listed)
- Scores of 21 or more on BDI and/or BAI
- History of head trauma
- History of a major psychological or neurological condition
- Presence of metal in the head
- History of seizures
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 |
|---|---|---|
| repetitive Transcranial Magnetic StimulationMagnetic pulses delivered to the Fz area of the brain in a low frequency (1 Hz) manner. | Device | Active rTMS |
Primary outcome
Change in performance
Time frame: Up to 10 days, i.e., before and after the completion of the 10 sessions of rTMS
Shortened version (4 min) of the continuous go/no-go task: gradual-onset continuous performance task (gradCPT)
2 secondary outcomes
Change in self-report attention scores
Time frame: Baseline, after 5 days of stimulation, after 10 days of stimulation; Range= 0-6; Higher scores represent worse outcome
Change in investigator-rated attention scores
Time frame: Baseline, after 5 days of stimulation, after 10 days of stimulation; Range:0 - 54; Higher scores represent worse outcome
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 14 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Attention Deficit Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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.
Reza Rostami, M.D study director
University of Tehran
Fatemeh Soltani, MSc principal investigator
University of Tehran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive Transcranial Magnetic Stimulation in people with Attention Deficit Disorder and ADHD, run by University of Tehran at 1 site in Iran.
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 8 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 14 Sep 2023. 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 Iran. 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?
Change in performance (time frame: Up to 10 days, i.e., before and after the completion of the 10 sessions of rTMS). 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 14 Sep 2023.