Attention Deficit Hyperactivity DisorderADHDNCT01651169
Methylphenidate on Intracortical Inhibition in Methamphetamine Abusers Attention Deficit Hyperactivity Disorder (ADHD)
A study testing methylphenidate tablets and Inter-stimulus Intervals (ISI) in people with Attention Deficit Hyperactivity Disorder, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Previous studies using transcranial magnetic stimulation (TMS) with paired pulse protocols have shown that a conditioning TMS pulse applied to the human motor cortex changes the excitability of motor pathways from the motor cortex to spinal motorneurons. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- methylphenidate tablets and Inter-stimulus Intervals (ISI)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Sep 2012to Mar 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV diagnosis of Methamphetamine abuse co morbid with ADHD
- Right handedness
Who cannot join
- Other current Axis I disorders (except simple phobia and nicotine addiction)
- Personal or close family history of seizure disorder
- Ferromagnetic material in body or close to head
- Neurologic disorder
- Pregnancy
- Taking medications known to lower seizure threshold (eg, theophylline)
Trial locations and contacts
1 site in 1 country.
Iran1 site
Javad Alaghband-rad
Tehran University of Medical Sciences, Tehran Province
About this study
Official title: Evaluating the Effect of Methylphenidate on Intracortical Inhibition in Methamphetamine Abusers Comorbid With Attention Deficit Disorder With Hyperactivity(ADHD) in TMS Unit, Neurcognitive Lab, Iranian National Center for Addiction Studies (INCAS), in 2012. A Randomized, Controlled Trial
Previous studies using transcranial magnetic stimulation (TMS) with paired pulse protocols have shown that a conditioning TMS pulse applied to the human motor cortex changes the excitability of motor pathways from the motor cortex to spinal motorneurons. These effects depended on the stimulus intensity of both conditioning and test pulse and also the ISI). A characteristical sequence of inhibition (short interval cortical inhibition [SICI], GABA-Aerg), facilitation (intracortical facilitation [ICF]), and inhibition again (long interval cortical inhibition [LICI], GABA-Berg) is thought to be physiologically involved in motor control. Previous studies have also shown that neuronal inhibitory motor circuits are also disturbed in ADHD which will be restored by using methylphenidate. In this study the investigators sought to investigate if methamphetamine abuse (from the same chemical class of medications) will alter such effects of methylphenidate.
Read the detailed description
Design:
Prospective, randomized, -controlled (1:1 randomization), duration-2 single sessions one week apart
Setting:
University psychiatric hospitals in Tehran including Roozbeh Hospital, Rasool Hospital and Imam Hossein General Hospital will refer clients to Iranian National Center for Addiction Studies, Tehran University of Medical Sciences.
Patients:
Fifteen patients with Methamphetamine abuse for at least 2 years plus ADHD are compared with a control group of 15 ADHD patients matched for age and gender
INTERVENTION:
We administer 2 single doses of methylphenidate tablets (10mg) separated by a week interval. A paired pulse protocols will be performed with ten single (unconditioned test pulse) and ten paired TMS pulses (conditioning and test pulse) in an intermixed randomized order.
Short interval cortical inhibition is measured with an Inter-stimulus Intervals (ISI) of 3 msec and a stimulator output of 80% RMT for the conditioning stimulus and 1mVT stimulation intensity for the test stimulus. ICF investigation is measured with an ISI of 13 msec), with the condition of an ISI of 50 msec (ISI 50) and both stimuli applied with 1mVT intensity). Long Interval Cortical Inhibition (LICI) is measured with ISIs of 100 msec (ISI 100), 200 msec (ISI 200), and 300 msec (ISI 300); both stimuli with 1mVT intensity.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- methylphenidate tablets and Inter-stimulus Intervals (ISI)
- Keywords
- Paired Transcranial Magnetic Stimulation, Methamphetamine abuse, ADHD, Methylphenidate, We study the effect of Methamphetamine abuse on Intracortical Inhibition, in ADHD patients, treated with Methylphenidate.
- 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.
methylphenidate tablets and Inter-stimulus Intervals (ISI)Other
We administer 2 single doses of methylphenidate tablets (10mg) separated by a week interval. A paired pulse protocols will be performed with ten single (unconditioned test pulse) and ten paired TMS pulses (conditioning and test pulse) in an intermixed randomized order.
Short interval cortical inhibition is measured with an Inter-stimulus Intervals (ISI) of 3 msec and a stimulator output of 80% RMT for the conditioning stimulus and 1mVT stimulation intensity for the test stimulus. ICF investigation is measured with an ISI of 13 msec), with the condition of an ISI of 50 msec (ISI 50) and both stimuli applied with 1mVT intensity). Long Interval Cortical Inhibition (LICI) is measured with ISIs of 100 msec (ISI 100), 200 msec (ISI 200), and 300 msec (ISI 300); both stimuli with 1mVT intensity
methylphenidate tablets and Inter-stimulus Intervals (ISI)Other
We administer 2 single doses of methylphenidate tablets (10mg) separated by a week interval. A paired pulse protocols will be performed with ten single (unconditioned test pulse) and ten paired TMS pulses (conditioning and test pulse) in an intermixed randomized order.
Short interval cortical inhibition is measured with an Inter-stimulus Intervals (ISI) of 3 msec and a stimulator output of 80% RMT for the conditioning stimulus and 1mVT stimulation intensity for the test stimulus. ICF investigation is measured with an ISI of 13 msec), with the condition of an ISI of 50 msec (ISI 50) and both stimuli applied with 1mVT intensity). Long Interval Cortical Inhibition (LICI) is measured with ISIs of 100 msec (ISI 100), 200 msec (ISI 200), and 300 msec (ISI 300); both stimuli with 1mVT intensity.
| Study group | Role | What they receive |
|---|---|---|
| methylphenidate tablets (10mg), ADHD | Experimental | Fifteen patients of ADHD Receives: Other: methylphenidate tablets and Inter-stimulus Intervals (ISI) |
| methylphenidate tablets, Methamphetamine abusers and ADHD | Experimental | Fifteen patients of ADHD with Methamphetamine abuse for at least 2 years plus Receives: Other: methylphenidate tablets and Inter-stimulus Intervals (ISI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conners ADHD Rating Scale
The primary outcome measure for the study is Conners which measure clinical improvement on ADHD symptoms
Measured: 1 week
Secondary outcomes (1)
Change of Motor Evoked Potential (MEP)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2015 (estimated)
- Study completionMar 2016 (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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Khazaeipour, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651169
- Sponsor's protocol ID
- 90-04-49-16359
- Acronym
- ADHD
- Status last verified
- Nov 2014
- First submitted
- 24 Jul 2012
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Methylphenidate on Intracortical Inhibition in Methamphetamine Abusers Comorbid With Attention Deficit Disorder With Hyperactivity(ADHD) in TMS Unit, Neurcognitive Lab, Iranian National Center for Addiction Studies (INCAS), in 2012. A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01651169
- Acronym / sponsor ID
- ADHD / 90-04-49-16359
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Paired Transcranial Magnetic Stimulation, Methamphetamine abuse, ADHD, Methylphenidate, We study the effect of Methamphetamine abuse on Intracortical Inhibition, in ADHD patients, treated with Methylphenidate.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 26 Jul 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.
Previous studies using transcranial magnetic stimulation (TMS) with paired pulse protocols have shown that a conditioning TMS pulse applied to the human motor cortex changes the excitability of motor pathways from the motor cortex to spinal motorneurons. These effects depended on the stimulus intensity of both conditioning and test pulse and also the ISI). A characteristical sequence of inhibition (short interval cortical inhibition [SICI], GABA-Aerg), facilitation (intracortical facilitation [ICF]), and inhibition again (long interval cortical inhibition [LICI], GABA-Berg) is thought to be physiologically involved in motor control. Previous studies have also shown that neuronal inhibitory motor circuits are also disturbed in ADHD which will be restored by using methylphenidate. In this study the investigators sought to investigate if methamphetamine abuse (from the same chemical class of medications) will alter such effects of methylphenidate.
Detailed description
Design:
Prospective, randomized, -controlled (1:1 randomization), duration-2 single sessions one week apart
Setting:
University psychiatric hospitals in Tehran including Roozbeh Hospital, Rasool Hospital and Imam Hossein General Hospital will refer clients to Iranian National Center for Addiction Studies, Tehran University of Medical Sciences.
Patients:
Fifteen patients with Methamphetamine abuse for at least 2 years plus ADHD are compared with a control group of 15 ADHD patients matched for age and gender
INTERVENTION:
We administer 2 single doses of methylphenidate tablets (10mg) separated by a week interval. A paired pulse protocols will be performed with ten single (unconditioned test pulse) and ten paired TMS pulses (conditioning and test pulse) in an intermixed randomized order.
Short interval cortical inhibition is measured with an Inter-stimulus Intervals (ISI) of 3 msec and a stimulator output of 80% RMT for the conditioning stimulus and 1mVT stimulation intensity for the test stimulus. ICF investigation is measured with an ISI of 13 msec), with the condition of an ISI of 50 msec (ISI 50) and both stimuli applied with 1mVT intensity). Long Interval Cortical Inhibition (LICI) is measured with ISIs of 100 msec (ISI 100), 200 msec (ISI 200), and 300 msec (ISI 300); both stimuli with 1mVT intensity.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylphenidate tablets (10mg), ADHD | Experimental | Other: methylphenidate tablets and Inter-stimulus Intervals (ISI)Fifteen patients of ADHD |
| methylphenidate tablets, Methamphetamine abusers and ADHD | Experimental | Other: methylphenidate tablets and Inter-stimulus Intervals (ISI)Fifteen patients of ADHD with Methamphetamine abuse for at least 2 years plus |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- DSM-IV diagnosis of Methamphetamine abuse co morbid with ADHD
- Right handedness
Key exclusion criteria (6 listed)
- Other current Axis I disorders (except simple phobia and nicotine addiction)
- Personal or close family history of seizure disorder
- Ferromagnetic material in body or close to head
- Neurologic disorder
- Pregnancy
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 |
|---|---|---|
| methylphenidate tablets and Inter-stimulus Intervals (ISI)We administer 2 single doses of methylphenidate tablets (10mg) separated by a week interval. A paired pulse protocols will be performed with ten single (unconditioned test pulse) and ten paired TMS pulses (conditioning and test pulse) in an intermixed randomized order. Short interval cortical inhibition is measured with an Inter-stimulus Intervals (ISI) of 3 msec and a stimulator output of 80% RMT for the conditioning stimulus and 1mVT stimulation intensity for the test stimulus. ICF investigation is measured with an ISI of 13 msec), with the condition of an ISI of 50 msec (ISI 50) and both stimuli applied with 1mVT intensity). Long Interval Cortical Inhibition (LICI) is measured with ISIs of 100 msec (ISI 100), 200 msec (ISI 200), and 300 msec (ISI 300); both stimuli with 1mVT intensity | Other | methylphenidate tablets (10mg), ADHD |
| methylphenidate tablets and Inter-stimulus Intervals (ISI)We administer 2 single doses of methylphenidate tablets (10mg) separated by a week interval. A paired pulse protocols will be performed with ten single (unconditioned test pulse) and ten paired TMS pulses (conditioning and test pulse) in an intermixed randomized order. Short interval cortical inhibition is measured with an Inter-stimulus Intervals (ISI) of 3 msec and a stimulator output of 80% RMT for the conditioning stimulus and 1mVT stimulation intensity for the test stimulus. ICF investigation is measured with an ISI of 13 msec), with the condition of an ISI of 50 msec (ISI 50) and both stimuli applied with 1mVT intensity). Long Interval Cortical Inhibition (LICI) is measured with ISIs of 100 msec (ISI 100), 200 msec (ISI 200), and 300 msec (ISI 300); both stimuli with 1mVT intensity. | Other | methylphenidate tablets, Methamphetamine abusers and ADHD |
Primary outcome
Conners ADHD Rating Scale
Time frame: 1 week
The primary outcome measure for the study is Conners which measure clinical improvement on ADHD symptoms
1 secondary outcome
Change of Motor Evoked Potential (MEP)
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
Related trials for Attention Deficit Hyperactivity 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing methylphenidate tablets and Inter-stimulus Intervals (ISI) in people with Attention Deficit Hyperactivity Disorder, run by Tehran University of Medical Sciences 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 6 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 18 Nov 2014. 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?
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?
Conners ADHD Rating Scale (time frame: 1 week). 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 18 Nov 2014.