Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05824221
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-21
First Post:
2023-04-05
Brief Title:
Effect of rTMS on Neurotrophines Levels in CUD
Sponsor:
ITAB - Institute for Advanced Biomedical Technologies
Organization:
ITAB - Institute for Advanced Biomedical Technologies
Study Overview
Official Title:
Effect of rTMS on BDNF and proBDNF Levels a Sham-controlled Study in Subjects With Cocaine Use Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
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:
BDNFcoca
Brief Summary:
Brief Summary
Background Cocaine use disorders CUD is a multifactoral disease involving several brain areas One of the most investigated is the Dorsolateral Prefrontal Cortex DLPFC involved in impulsiveness control Effective treatments for CUD are still needed and repetitive Transcranial Magnetic Stimulation rTMS is widely studied for its potential in reducing cocaine craving and consumption
Objectives The main outcome is to test if rTMS can be related to neuroplasticity and neurotrophism through changes in Brain-Derived Neurotrophic Factor BDNF and its precursor pro-BDNF levels
Eligibility Healthy right-handed adults ages 18-65 who do have cocaine use disorder moderate to severe
Design This is a randomized sham-controlled study The study includes a rTMS continued treatment phase compared to healthy control HC evaluation
Prior to participating participants will be screened with
Medical history
Anamnestic sheet
Physical exam
Urine tests After being enrolled participants and HC will undergo venous blood sample BDNF and proBDNF levels
During the continued rTMS phase participants with cocaine use disorder will be randomized to receive real or sham rTMS a former arm is also provided and is made up of HC RTMS will be delivered in 10 days over 2 weeks 5 daysweek After the last rTMS session a blood sample for neurotrophines levels will be collected
Treatment includes
rTMS A coil is placed on the head At each session participants will receive two rTMS sessions with a 50 mins interval At the beginning of each rTMS session they view cocaine-related images for few minutes cue-induced stimuli
BDNFproBDNF levels A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period first two weeks this sample will be also collected from HC The blood sample will be centrifuged within 20 minutes of sampling at 1000 g for 15 minutes Then the serum will be aliquoted and stored at -80 C until analysis
Urine toxicological screen
Background Cocaine use disorders CUD is a multifactoral disease involving several brain areas One of the most investigated is the Dorsolateral Prefrontal Cortex DLPFC involved in impulsiveness control Effective treatments for CUD are still needed and repetitive Transcranial Magnetic Stimulation rTMS is widely studied for its potential in reducing cocaine craving and consumption
Objectives The main outcome is to test if rTMS can be related to neuroplasticity and neurotrophism through changes in Brain-Derived Neurotrophic Factor BDNF and its precursor pro-BDNF levels
Eligibility Healthy right-handed adults ages 18-65 who do have cocaine use disorder moderate to severe
Design This is a randomized sham-controlled study The study includes a rTMS continued treatment phase compared to healthy control HC evaluation
Prior to participating participants will be screened with
Medical history
Anamnestic sheet
Physical exam
Urine tests After being enrolled participants and HC will undergo venous blood sample BDNF and proBDNF levels
During the continued rTMS phase participants with cocaine use disorder will be randomized to receive real or sham rTMS a former arm is also provided and is made up of HC RTMS will be delivered in 10 days over 2 weeks 5 daysweek After the last rTMS session a blood sample for neurotrophines levels will be collected
Treatment includes
rTMS A coil is placed on the head At each session participants will receive two rTMS sessions with a 50 mins interval At the beginning of each rTMS session they view cocaine-related images for few minutes cue-induced stimuli
BDNFproBDNF levels A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period first two weeks this sample will be also collected from HC The blood sample will be centrifuged within 20 minutes of sampling at 1000 g for 15 minutes Then the serum will be aliquoted and stored at -80 C until analysis
Urine toxicological screen
Detailed Description:
RTMS has been shown to reduce craving in CUD The purpose of this study is to assess the effects of rTMS at 15 Hz frequency on neurotrophines serum levels For this purpose the investigators will recruit cocaine user After screening and informed consent participants will undergo active or sham rTMS for two consecutive weeks twice a day during the continued treatment phase a third arm of HC will receive no treatment A venous blood sample will be collected before the first stimulation and after the last stimulation of the first two weeks treatment
Procedure The project consists of Screening Visit baseline and the continued treatment phase In the screening visit a clinical interview to assess the eligibility of participant following the inclusion and exclusion criteria will be performed All participants will be randomly assigned to one of the two treatment arms with rTMS 15Hz 15Hz-Sham Participants will receive 2 sessions of rTMS active or sham twice per day for 10 consecutive days for a total of 20 rTMS sessions A venous blood sample will be collected before the first stimulation and after the last stimulation of the continued treatment phase to asses the BDNF and pro-BDNF level
Procedure The project consists of Screening Visit baseline and the continued treatment phase In the screening visit a clinical interview to assess the eligibility of participant following the inclusion and exclusion criteria will be performed All participants will be randomly assigned to one of the two treatment arms with rTMS 15Hz 15Hz-Sham Participants will receive 2 sessions of rTMS active or sham twice per day for 10 consecutive days for a total of 20 rTMS sessions A venous blood sample will be collected before the first stimulation and after the last stimulation of the continued treatment phase to asses the BDNF and pro-BDNF level
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?:
False
Is an FDA AA801 Violation?:
None