Ignite Creation Date:
2024-05-06 @ 10:14 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03207633
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2017-06-24
Brief Title:
Low Frequency TMS on DLPFC and OFC in OCD Patients
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Comparative Study of the Therapeutic Effect of Low Frequency TMS on DLPFC and OFC in OCD Patients
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the therapeutic effect of low frequency rTMS over the right DLPFC versus right OFC versus Sham group of obsessive-compulsive disorder OCD patients Sixty patients will be recruited from the out-patient psychiatric clinic of a university hospital and randomized into three equal groups The 1st group will receive 10 sessions of low frequency rTMS targeting right DLPFC by means of a butterfly coil 120 RMT 1 Hz 3 trains each of 500 pulses with a 40 seconds inter-train interval allowing the coil to cool The 2nd group will receive 10 sessions of low-frequency rTMS over the right orbitofrontal cortex OFC the international 10-20 EEG system will be used to position the coil over the right OFC at the right frontopolar 2 Fp2 electrode site using the following parameters 120 motor threshold 1 Hz 3 trains each of 500 pulses with a 40 seconds inter-train interval allowing the coil to cool The 3rd group will receive sham stimulations with the same pulse delivery as the other groups but with the coil placed perpendicular to the scalp
The resting motor threshold RMT and cortical silent period CSP at different intensities from 110 to 150 will be measured before and after the end of sessions All assessments like Y-BOCS HAM-A Beck Depression Inventory CGI-S MoCA will be performed before and after end of the sessions and 3 months later
The resting motor threshold RMT and cortical silent period CSP at different intensities from 110 to 150 will be measured before and after the end of sessions All assessments like Y-BOCS HAM-A Beck Depression Inventory CGI-S MoCA will be performed before and after end of the sessions and 3 months later
Detailed Description:
This study aims to evaluate the therapeutic effect of low frequency rTMS over the right DLPFC versus right OFC versus Sham group of OCD patients Sixty patients will be recruited from the out-patient psychiatric clinic of a university hospital the patients will be randomized into three groups 20 patients for each group using closed envelopes
The first group 20 patients will receive 10 sessions of low frequency rTMS targeting right DLPFC by means of a Butterfly coil The DLPFC stimulation site was defined as the region 5 cm dorsolateral in the same sagittal plane as the optimal site for MT production in the first dorsal interosseous using the following parameters 120 RMT 1 Hz 3 trains each of 500 pulses with a 40 seconds inter-train interval allowing the coil to cool
The second group 20 patients will receive 10 sessions of low-frequency rTMS over the right orbitofrontal cortex OFC by means of a butterfly coil the international 10-20 EEG system will be used to position the coil over the right OFC at the right frontopolar 2 Fp2 electrode site using the following parameters 120 motor threshold 1 Hz 3 trains each of 500 pulses with a 40 seconds inter-train interval allowing the coil to cool
The third group the sham condition 20 patients group will receive sham stimulations with the same pulse delivery as the other groups but with the coil placed perpendicular to the scalp
The resting motor threshold RMT and cortical silent period CSP at different intensities from 110 to 150 will be measured before and after the end of sessions All assessments like Y-BOCS HAM-A Beck Depression Inventory CGI-S MoCA will be performed before and after end of the sessions and 3 months later
The first group 20 patients will receive 10 sessions of low frequency rTMS targeting right DLPFC by means of a Butterfly coil The DLPFC stimulation site was defined as the region 5 cm dorsolateral in the same sagittal plane as the optimal site for MT production in the first dorsal interosseous using the following parameters 120 RMT 1 Hz 3 trains each of 500 pulses with a 40 seconds inter-train interval allowing the coil to cool
The second group 20 patients will receive 10 sessions of low-frequency rTMS over the right orbitofrontal cortex OFC by means of a butterfly coil the international 10-20 EEG system will be used to position the coil over the right OFC at the right frontopolar 2 Fp2 electrode site using the following parameters 120 motor threshold 1 Hz 3 trains each of 500 pulses with a 40 seconds inter-train interval allowing the coil to cool
The third group the sham condition 20 patients group will receive sham stimulations with the same pulse delivery as the other groups but with the coil placed perpendicular to the scalp
The resting motor threshold RMT and cortical silent period CSP at different intensities from 110 to 150 will be measured before and after the end of sessions All assessments like Y-BOCS HAM-A Beck Depression Inventory CGI-S MoCA will be performed before and after end of the sessions and 3 months later
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None