Substance Use DisordersNCT06066164
Transcranial Magnetic Stimulation in Substance Use Disorder Patients
A study testing Transcranial magnetic stimulation (TMS) in people with Substance Use Disorders, run by Assiut University.
Trial summary
To determine the effect of substance use disorder on cortical excitability using transcranial magnetic stimulation (TMS) , it's a scientific study Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Transcranial magnetic stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to 1 Oct 2024
- 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 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age:above18yearsold
- males only
- Patients fulfilling diagnostic criteria of substance use disorder according to DSM-5
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Conditions
- Substance Use Disorders
- Being tested
- Transcranial magnetic stimulation (TMS)
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulation (TMS)Device
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Not described Receives: Device: Transcranial magnetic stimulation (TMS) |
| Polysubstance use disorder patients | Active comparator | Not described Receives: Device: Transcranial magnetic stimulation (TMS) |
| Monosubstance use disorder patients | Active comparator | Not described Receives: Device: Transcranial magnetic stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study startDec 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Goda, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066164
- Sponsor's protocol ID
- Tms in SUD patients
- Status last verified
- Sep 2023
- First submitted
- 27 Sep 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Excitability Among Substance Use Disorder Patients
- ClinicalTrials.gov ID
- NCT06066164
- Acronym / sponsor ID
- Tms in SUD patients
- Conditions
- Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 4 Oct 2023 (actual)
- 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.
To determine the effect of substance use disorder on cortical excitability using transcranial magnetic stimulation (TMS) , it's a scientific study
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Device: Transcranial magnetic stimulation (TMS) |
| Polysubstance use disorder patients | Active comparator | Device: Transcranial magnetic stimulation (TMS) |
| Monosubstance use disorder patients | Active comparator | Device: Transcranial magnetic stimulation (TMS) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age:above18yearsold
- males only
- Patients fulfilling diagnostic criteria of substance use disorder according to DSM-5
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| 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 | Device | Control group, Monosubstance use disorder patients, Polysubstance use disorder patients |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation (TMS) in people with Substance Use Disorders, run by Assiut University.
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 3 inclusion and 1 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 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Abdelrahman H Goda (01061236939, Abdelrahmangoda17@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure cortical excitability in substance use disorder patients by TMS (time frame: Baseline). 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 4 Oct 2023.