Methylphenidate on Intracortical Inhibition in Methamphetamine Abusers Attention Deficit Hyperactivity Disorder (ADHD) (ADHD)

• ClinicalTrials.gov Identifier: NCT01651169
• Recruitment Status: Unknown
• First Posted: July 26, 2012
• Last Update Posted: November 18, 2014
• Sponsor: Tehran University of Medical Sciences
• Information provided by (Responsible Party): Zahra Khazaeipour, Tehran University of Medical Sciences

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Attention Deficit Hyperactivity Disorder	Other: methylphenidate tablets and Inter-stimulus Intervals (ISI)	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• 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
• Study Start Date: September 2012
• Estimated Primary Completion Date: November 2015
• Estimated Study Completion Date: March 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: methylphenidate tablets (10mg), ADHD; Fifteen patients of ADHD	Other: 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
Experimental: methylphenidate tablets, Methamphetamine abusers and ADHD; Fifteen patients of ADHD with Methamphetamine abuse for at least 2 years plus	Other: 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.

Outcome Measures

Primary Outcome Measures :

1. Conners ADHD Rating Scale [ Time Frame: 1 week ]
   The primary outcome measure for the study is Conners which measure clinical improvement on ADHD symptoms

Secondary Outcome Measures :

1. Change of Motor Evoked Potential (MEP) [ Time Frame: 1 week ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• DSM-IV diagnosis of Methamphetamine abuse co morbid with ADHD
• Right handedness

Exclusion Criteria:

• 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)

Contacts and Locations

Locations

Iran, Islamic Republic of

Javad Alaghband-rad

Tehran University of Medical Sciences, Tehran, Iran, Islamic Republic of

Sponsors and Collaborators

Tehran University of Medical Sciences

More Information

• Responsible Party: Zahra Khazaeipour, M.D., MPH., Tehran University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT01651169
• Other Study ID Numbers: 90-04-49-16359
• First Posted: July 26, 2012
• Last Update Posted: November 18, 2014
• Last Verified: November 2014

Keywords provided by Zahra Khazaeipour, Tehran University of Medical Sciences:

Paired Transcranial Magnetic Stimulation; Methamphetamine abuse, ADHD, Methylphenidate; We study the effect of Methamphetamine abuse on Intracortical Inhibition, in ADHD patients, treated with Methylphenidate.

Additional relevant MeSH terms:

Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Methylphenidate; Central Nervous System Stimulants; Physiological Effects of Drugs; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents