The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transcranial Magnetic Stimulation in Substance Use Disorder Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06066164
Recruitment Status : Not yet recruiting
First Posted : October 4, 2023
Last Update Posted : October 4, 2023
Sponsor:
Information provided by (Responsible Party):
Abdelrahman Goda, Assiut University

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

Condition or disease Intervention/treatment Phase
Substance Use Disorders Device: Transcranial magnetic stimulation (TMS) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cortical Excitability Among Substance Use Disorder Patients
Estimated Study Start Date : December 2023
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : October 1, 2024

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




Primary Outcome Measures :
  1. Measure cortical excitability in substance use disorder patients by TMS [ Time Frame: Baseline ]
    Estimation of cortical excitability in substance use disorder patients and compare it in mono substance use disorder patients and poly substance use disorder patients



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06066164


Contacts
Layout table for location contacts
Contact: Abdelrahman H Goda 01061236939 Abdelrahmangoda17@gmail.com

Sponsors and Collaborators
Assiut University
Layout table for additonal information
Responsible Party: Abdelrahman Goda, AbdGoda, Assiut University
ClinicalTrials.gov Identifier: NCT06066164    
Other Study ID Numbers: Tms in SUD patients
First Posted: October 4, 2023    Key Record Dates
Last Update Posted: October 4, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders