Your session is about to expire
← Back to Search
Behavioral Intervention
Neurofeedback + TMS for Alcoholism (CNT Trial)
N/A
Waitlist Available
Led By Samantha J Fede, PhD
Research Sponsored by Auburn University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)
Awards & highlights
CNT Trial Summary
This trial studies if MRI and TMS can help people with Alcohol Use Disorder. Participants will come in for 4 weeks of intervention and follow-up visits for up to a year.
Who is the study for?
This trial is for adults aged 19-65 who are currently receiving treatment for Alcohol Use Disorder. It's not suitable for those with significant head injuries, claustrophobia that prevents MRI scans, neurological diseases, seizure history, certain metal implants or body metal including facial tattoos, medications lowering seizure threshold, active alcohol withdrawal symptoms, hearing loss worsened by MRI/TMS or a family history of schizophrenia.Check my eligibility
What is being tested?
The study tests if additional fMRI neurofeedback and TMS (Transcranial Magnetic Stimulation) can help people being treated for Alcohol Use Disorder. Participants will undergo weekly sessions over four weeks and have follow-ups via remote contact monthly up to one year with two extra MRI sessions at six and twelve months.See study design
What are the potential side effects?
Potential side effects from the interventions may include discomfort from the TMS procedure like scalp pain or headache during and after treatment. The fMRI process is generally safe but might cause unease due to loud noises or confinement in the machine.
CNT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Aggression and Victimization over Time
Ethanol
Alcohol Use Disorder
+5 moreSecondary outcome measures
Brain
Brain
Change in Resting State Functional Connectivity over Time
CNT Trial Design
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Neurofeedback-active + TMS-activeExperimental Treatment2 Interventions
4 sessions of: TMS (protocol: 10 Hz pulses delivered at 110% of MT in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of own brain activity from multiple ROIs measured using fMRI)
Group II: Neurofeedback-active + TMS-shamActive Control2 Interventions
4 sessions of: TMS (protocol: 10 Hz pulses delivered using the Sham TMS coil in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of own brain activity from multiple ROIs measured using fMRI)
Group III: Check-In OnlyActive Control1 Intervention
4 sessions of: Completing typical pre-TMS/MRI procedures Being prompted to reflect on outside treatment (TAU)
Group IV: Neurofeedback-sham + TMS-activeActive Control2 Interventions
4 sessions of: TMS (protocol: 10 Hz pulses delivered at 110% of MT in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of other's brain activity from multiple ROIs measured using fMRI)
Group V: Neurofeedback-sham + TMS-shamPlacebo Group2 Interventions
4 sessions of: TMS (protocol: 10 Hz pulses delivered using the Sham TMS coil in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of other's brain activity from multiple ROIs measured using fMRI)
Find a Location
Who is running the clinical trial?
Auburn UniversityLead Sponsor
72 Previous Clinical Trials
14,315 Total Patients Enrolled
1 Trials studying Alcoholism
87 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
800 Previous Clinical Trials
1,362,907 Total Patients Enrolled
423 Trials studying Alcoholism
985,618 Patients Enrolled for Alcoholism
Samantha J Fede, PhDPrincipal InvestigatorAuburn University
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a medical device implanted in my head or one that uses body signals.I do not have metal in my body that would interfere with a 7T MRI.I have had a neurological condition like a stroke or brain tumor.I have had a seizure or have a family history of epilepsy.I have had a head injury where I was unconscious for more than 30 minutes.I am between 19 and 65 years old.I have a family history of schizophrenia or have experienced psychotic symptoms.I am taking medication that could increase my risk of seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Neurofeedback-sham + TMS-sham
- Group 2: Neurofeedback-active + TMS-sham
- Group 3: Check-In Only
- Group 4: Neurofeedback-sham + TMS-active
- Group 5: Neurofeedback-active + TMS-active
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any criteria for being accepted as a participant in this clinical assessment?
"This clinical trial aims to recruit up to 90 individuals aged 19-65 who are currently receiving treatment for Alcohol Use Disorder."
Answered by AI
Is the age requirement for this clinical trial restricted to those under 30?
"This medical trial will consider participants aged 19 and over, but no older than 65."
Answered by AI
Are there any opportunities for individuals to participate in this research initiative currently?
"As of this moment, ClinicalTrials.gov does not note any recruitment for the trial that was initially posted on June 1st 2023 and last modified November 10th 2022. Nevertheless, there are 365 other clinical trials currently enrolling participants."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger