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

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

Sponsors

Lead Sponsor: Tehran University of Medical Sciences

Source Tehran University of Medical Sciences
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.

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.

Overall Status Unknown status
Start Date September 2012
Completion Date March 2016
Primary Completion Date November 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Conners ADHD Rating Scale 1 week
Secondary Outcome
Measure Time Frame
Change of Motor Evoked Potential (MEP) 1 week
Enrollment 30
Condition
Intervention

Intervention Type: Other

Intervention Name: methylphenidate tablets and Inter-stimulus Intervals (ISI)

Description: 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

Arm Group Label: methylphenidate tablets (10mg), ADHD

Intervention Type: Other

Intervention Name: methylphenidate tablets and Inter-stimulus Intervals (ISI)

Description: 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.

Arm Group Label: methylphenidate tablets, Methamphetamine abusers and ADHD

Eligibility

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Location
Facility: Javad Alaghband-rad
Location Countries

Iran, Islamic Republic of

Verification Date

November 2014

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Tehran University of Medical Sciences

Investigator Full Name: Zahra Khazaeipour

Investigator Title: M.D., MPH.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: methylphenidate tablets (10mg), ADHD

Type: Experimental

Description: Fifteen patients of ADHD

Label: methylphenidate tablets, Methamphetamine abusers and ADHD

Type: Experimental

Description: Fifteen patients of ADHD with Methamphetamine abuse for at least 2 years plus

Acronym ADHD
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov