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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04691167
Other study ID # r-TMS
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2022
Est. completion date October 2022

Study information

Verified date April 2022
Source Ain Shams University
Contact Noha Ahmed saad, bch,MS
Phone 01227666923
Email nohaahmedsaad@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Repetitive Trans-cranial Magnetic Stimulation (rTMS) is a relatively safe and non-invasive method to modulate neuronal activity; rTMS uses alternating magnetic fields in a certain frequency to induce an electric current in the underlying brain tissue. Administering high frequency rTMS to the left dorsolateral prefrontal cortex is possible to increase brain activity in the stimulated area and to change brain activity in associated regions that are part of the same neural circuit which may reduce craving.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 52
Est. completion date October 2022
Est. primary completion date August 2022
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: 1. Age range: 18-45 years old 2. Gender: males 3. Opioid Use disorder according to the DSM-5 (early abstinence starting 1 week up to 1 month). Exclusion Criteria: 1. Presence of other serious mental illness (e.g.; psychotic disorders, bipolar affective disorder, depression with psychotic features). 2. Patients with any other serious medical illness. 3. Previous treatment with repetitive Trans- cranial magnetic stimulation. 4. Patients with contraindications to rTMS as cardiac patient with pacemaker.

Study Design


Intervention

Device:
repetitive trans magnetic stimulation
Repetitive Trans-cranial Magnetic Stimulation (rTMS) is a relatively safe and non-invasive method to modulate neuronal activity; rTMS uses alternating magnetic fields in a certain frequency to induce an electric current in the underlying brain tissue.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Outcome

Type Measure Description Time frame Safety issue
Primary craving severity measure severity of drug craving using craving severity scale, the scale is called brief substance craving scale. a higher outcome is a worse result 6 weeks
Primary heroin craving using the heroin craving questionnaire, a higher score indicates a worse outcome 6 weeks
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