NCT06066164

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 4, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

September 27, 2023

Last Update Submit

September 27, 2023

Conditions

Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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)

Interventions

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

Control groupMonosubstance use disorder patientsPolysubstance use disorder patients

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age:above18yearsold
  • males only
  • Patients fulfilling diagnostic criteria of substance use disorder according to DSM-5

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Central Study Contacts

Abdelrahman H Goda

CONTACT

01061236939Abdelrahmangoda17@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
AbdGoda

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 4, 2023

Study Start

December 1, 2023

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

October 4, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share