Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06189690
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-12-19
Brief Title:
Effect of HF rTMS on Serum BDNF in Cocaine Use Disorder
Sponsor:
Instituto Nacional de Psiquiatría Dr Ramón de la Fuente
Organization:
Instituto Nacional de Psiquiatría Dr Ramón de la Fuente
Study Overview
Official Title:
Effects of 5-Hz Repetitive Transcranial Magnetic Stimulation on Serum Brain Derived Neurotrophic Factor and Clinical Variables in Cocaine Use Disorder
Status:
RECRUITING
Status Verified Date:
2023-12
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 explore the effect of 5-Hz rTMS over the left dorsolateral prefrontal cortex on the BDNF craving and cognitive function This study will be longitudinal with a short-term double-blind placebo-controlled phase consisting of 20 rTMS sessions and a long-term phase consisting of 2 weekly sessions for 12 weeks Participants will be clinically assessed pre-treatment T0 after 20-sessions phase T1 and after 12-weeks phase T2 by an interview about psychiatric symptoms Also blood will be obtained in the same T0 T1 and T2 to peripheral levels of BDNF determination Cognitive state will be measured at the same time-points T0 T1 T2 by paper-pencil and computerized neuropsychological assessment Researchers will compare active rTMS versus placebo 5 Hz-rTMS on described variables Additionally a comparative group without rTMS intervention will be included to equivalently measure described variables during periods without cocaine consumption
Detailed Description:
Brain derived neurotrophic factor BDNF is a widely explored neurotrophin in preclinical models of cocaine addiction with relevant phase and region dependent dynamics along addictive cycle In humans with cocaine use disorder CUD peripheral BDNF have revealed relationship with relevant treatment outcomes as relapse and time of abstinence In CUD several interventional studies using high frequency repetititve transcranial magnetic stimulation rTMS have shown craving reduction mood improvements and sustained modifications in functional conectivity measued by fMRI Due to the relevance of BDNF in CUD and neuroplasticity-related processes derived from rTMS interventions this study aims to determine changes in peripheral BDNF craving cognition in CUD in reponse to rTMS Aditionally other outcomes will be considered as depression anxiety and motivational changes
Procedure Psychiatric clinical and cognitive assessment and blood collection will be performed at T0 T1 and T2 time-points Short-term rTMS phase will consist of two weeks weekdays with 2 rTMS or rTMS-placebo sessions detaills in arms section Then two sessions per week along 12 weeks as maintenance therapy will be considered No rTMS group will attend the same time points and assessment in a controlled facility
Procedure Psychiatric clinical and cognitive assessment and blood collection will be performed at T0 T1 and T2 time-points Short-term rTMS phase will consist of two weeks weekdays with 2 rTMS or rTMS-placebo sessions detaills in arms section Then two sessions per week along 12 weeks as maintenance therapy will be considered No rTMS group will attend the same time points and assessment in a controlled facility
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