Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04897295
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-10-26
First Post:
2021-02-27
Brief Title:
Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder
Sponsor:
ITAB - Institute for Advanced Biomedical Technologies
Organization:
ITAB - Institute for Advanced Biomedical Technologies
Study Overview
Official Title:
Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder a Sham-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-10
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:
Background Alcohol Use Disorder AUD is a complex psychiatric disorder involving several brain areas and neurocircuits Transcranial Direct Current Stimulation tDCS allows to stimulate superficial areas of brain using a weak electrical current Preliminary data suggest that tDCS may reduce alcohol craving and consumption
Objectives The main outcome is to test if tDCS can reduce alcohol craving and use and to assess the changes in BDNF and pro-BDNF levels Secondary outcomes are the assessment of other psychiatric dimensions mood behavioral and cognitive alterations associated with prolonged alcohol use
Eligibility Healthy right-handed adults ages 18-65 who do have AUD moderate to severe
Design This is a randomized double-blind sham-controlled study with three phases 1 a tDCS intensive treatment phase 2 follow-up with weekly tDCS stimulation 3 follow-up without tDCS stimulation
Participants will be screened with
Psychometric Scales
Medical history
Physical exam
Urine tests and breathalyzer
After being enrolled baseline behavioral and laboratory data will be collected In particular participants will undergo
Psychometric Scales
Venous blood sample BDNFproBDNF levels
Participants will be randomized to real or sham tDCS arm The stimulation will be delivered daily for five days during the first week intensive treatment phase and then weekly for 3 months follow-up with stimulation During this period patient will be tested with a behavioral and psychometric evaluationTherefore participants will receive 3 follow-up monthly visits without tDCS stimulation in which behavioral and psychometric data will be collected
Treatment includes
tDCS The tDCS will be delivered with a stimulator connected to two sponge electrodes soaked in a saline solution The stimulation will be administered at a current intensity of approximately 1 mA for the duration of 20 minutes The anode will be placed on the right DLPFC the cathode on the contralateral cortical area
BDNFproBDNF levels A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period first week 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
Repeat of screening tests and questionnaires
Urine toxicological screen and breathalyzer
Objectives The main outcome is to test if tDCS can reduce alcohol craving and use and to assess the changes in BDNF and pro-BDNF levels Secondary outcomes are the assessment of other psychiatric dimensions mood behavioral and cognitive alterations associated with prolonged alcohol use
Eligibility Healthy right-handed adults ages 18-65 who do have AUD moderate to severe
Design This is a randomized double-blind sham-controlled study with three phases 1 a tDCS intensive treatment phase 2 follow-up with weekly tDCS stimulation 3 follow-up without tDCS stimulation
Participants will be screened with
Psychometric Scales
Medical history
Physical exam
Urine tests and breathalyzer
After being enrolled baseline behavioral and laboratory data will be collected In particular participants will undergo
Psychometric Scales
Venous blood sample BDNFproBDNF levels
Participants will be randomized to real or sham tDCS arm The stimulation will be delivered daily for five days during the first week intensive treatment phase and then weekly for 3 months follow-up with stimulation During this period patient will be tested with a behavioral and psychometric evaluationTherefore participants will receive 3 follow-up monthly visits without tDCS stimulation in which behavioral and psychometric data will be collected
Treatment includes
tDCS The tDCS will be delivered with a stimulator connected to two sponge electrodes soaked in a saline solution The stimulation will be administered at a current intensity of approximately 1 mA for the duration of 20 minutes The anode will be placed on the right DLPFC the cathode on the contralateral cortical area
BDNFproBDNF levels A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period first week 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
Repeat of screening tests and questionnaires
Urine toxicological screen and breathalyzer
Detailed Description:
Transcranial Direct Current Stimulation tDCS consists in the application on the scalp of electrodes anode and cathode delivering a direct current of low intensity that cannot be perceived by the stimulated subject In recent years tDCS stimulation has been increasingly used in psychiatric clinical research and in the addiction field Although there are some studies showing the anti-craving action of tDCS in alcohol use disorder AUD there are some differences between the stimulation parameters used in these works Furthermore there is a lack in the international scientific literature of studies that have investigated the neurobiological basis of tDCS activity This double-blind randomized sham-controlled trial consist in an intensive daily tDCS stimulation for the first week then 3 months of follow up with tDCS stimulation one tDCS stimulationweek and then 3 months of follow up without tDCS stimulation Psychometric evaluations will be performed at baseline end of the first week of stimulation 2 weeks 3 months 6 months A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive first week treatment The primary outcome of the study is the evaluation of the short-term clinical efficacy of the application of tDCS in subjects with AUD applying a anodal stimulation 1 mA on the right Dorso-Lateral Prefrontal Cortex DLPFC for 20 minutes for 5 consecutive days The results on some psychiatric psychometric scales examine possible changes in mood cognition and other psychiatric domains will represent additional criteria Another outcome is to assess the neuromodulation at the level of DLPFC evaluating the changes in serum levels of the brain-derived neurotrophic factor BDNF and its precursor pro-BDNF After screening and informed consent participants will undergo active or sham tDCS for one week during the intensive treatment phase and a maintenance intervention twice a week for 3 months during the tDCS follow-up phase Following this phase participants will be followed for further 3 months during which no rTMS will be delivered but clinical and imaging data will be collected
Procedure The project consists of Screening Visit baseline phase 1 intensive treatment phase phase 2 3 months- tDCS follow-up phase 3 3 months follow-up without rTMS In the screening visit a clinical interview to assess the eligibility of participant following the inclusion and exclusion criteria will be performed The signature of the informed consent and the baseline clinical and cognitive data will be acquired In Phase 1 all participants will be randomized in the active or sham arm Participants will receive 20 minutes of anodal right DLPFC stimulation for 5 consecutive days The assessor will evaluate the acute effect of treatment on craving consumption and on the psychometric variable considered at the end of this phase A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period to asses the BDNF and pro-BDNF level In Phase 2 each participant will undergo the same treatment active or sham of the Phase 1 for three months receiving stimulation once per week The same psychometric and behavioral data of the phase 1 will be collected monthly During Phase 3 participants will not receive any tDCS stimulation Also in this phase the same psychometric and behavioral data of the phase 1 will be collected monthly
Procedure The project consists of Screening Visit baseline phase 1 intensive treatment phase phase 2 3 months- tDCS follow-up phase 3 3 months follow-up without rTMS In the screening visit a clinical interview to assess the eligibility of participant following the inclusion and exclusion criteria will be performed The signature of the informed consent and the baseline clinical and cognitive data will be acquired In Phase 1 all participants will be randomized in the active or sham arm Participants will receive 20 minutes of anodal right DLPFC stimulation for 5 consecutive days The assessor will evaluate the acute effect of treatment on craving consumption and on the psychometric variable considered at the end of this phase A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period to asses the BDNF and pro-BDNF level In Phase 2 each participant will undergo the same treatment active or sham of the Phase 1 for three months receiving stimulation once per week The same psychometric and behavioral data of the phase 1 will be collected monthly During Phase 3 participants will not receive any tDCS stimulation Also in this phase the same psychometric and behavioral data of the phase 1 will be collected monthly
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