Transcranial Magnetic Stimulation in Substance Use Disorder Patients

Cortical Excitability Among Substance Use Disorder Patients

To determine the effect of substance use disorder on cortical excitability using transcranial magnetic stimulation (TMS) , it's a scientific study

Study Overview

• Status: Not yet recruiting
• Conditions: Substance Use Disorders
• Intervention / Treatment: Device: Transcranial magnetic stimulation (TMS)

Detailed Description

The numbers for substance use disorders are large, and we need to pay attention to them. Data from the 2018 National Survey on Drug Use and Health suggest that, over the preceding year, 20.3 million people age 12 or older had substance use disorders, and 14.8 million of these cases were attributed to alcohol. When considering other substances, the report estimated that 4.4 million individuals had a marijuana use disorder and that 2 million people suffered from an opiate use disorder. It is well known that stress is associated with an increase in the use of alcohol and other substances, and this is particularly relevant today in relation to the chronic uncertainty and distress associated with the COVID-19 pandemic along with the traumatic effects of racism and social injustice,Trans-cranial magnetic stimulation (TMS) is a safe and painless technique for evoking activity in neurons in the human brain through the intact scalp and skull). Since its introduction in the mid-1980s is used to evaluate the cortico-spinal tract, cortical motor areas,, map motor and cognitive functions, study neural networks, and modulate brain function with a potential therapeutic aim, On one hand, the development of specific stimulation protocols, such as the cortical silent period (CSP) and paired-pulse paradigms, as well as the emerging concept that motor cortical output is affected by non-primary motor areas, including the ventral and dorsal premotor cortex, supplementary motor area, and cingulate cortex, has allowed the use of TMS to explore inhibitory and excitatory interactions within motor cortical regions in several neuropsychiatric disorders. Different TMS protocols can be used to study different components of cortical excitability and provide insight in to the regulation of different neurotransmitter systems.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdelrahman H Goda; Phone Number: 01061236939; Email: Abdelrahmangoda17@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age:above18yearsold
2. males only
3. Patients fulfilling diagnostic criteria of substance use disorder according to DSM-5

Exclusion Criteria:

• 1. patients with other comorbid psychatric disorders. 2-patients with medical disease. 3.patients wirh epilepsy or family history of epilepsy. 4-cardiac pacemaker 5-metal implants in head as participant will be applied to magnetic field of the TMS 6-age yonnger than 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group	Device: Transcranial magnetic stimulation (TMS); Trans-cranial magnetic stimulation (TMS) is a safe and painless technique for evoking activity in neurons in the human brain through the intact scalp and skull To measure cortical excitability
Active Comparator: Polysubstance use disorder patients	Device: Transcranial magnetic stimulation (TMS); Trans-cranial magnetic stimulation (TMS) is a safe and painless technique for evoking activity in neurons in the human brain through the intact scalp and skull To measure cortical excitability
Active Comparator: Monosubstance use disorder patients	Device: Transcranial magnetic stimulation (TMS); Trans-cranial magnetic stimulation (TMS) is a safe and painless technique for evoking activity in neurons in the human brain through the intact scalp and skull To measure cortical excitability

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure cortical excitability in substance use disorder patients by TMS	Estimation of cortical excitability in substance use disorder patients and compare it in mono substance use disorder patients and poly substance use disorder patients	Baseline

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: September 27, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: Tms in SUD patients

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No