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VRT as a Biomarker of Cerebellar Dysfunction in Chronic Cannabis Use

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ClinicalTrials.gov Identifier: NCT03662737
Recruitment Status : Not yet recruiting
First Posted : September 7, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Antoni Gual, Hospital Clinic of Barcelona

Brief Summary:

Chronic cannabis consumption has been associated with poor psychosocial functioning that could be associated to cerebellar dysfunction. The cerebellum has a relevant role in adaptation processes and has a high density of cannabinoid 1 receptor (CB1R). Implicit motor learning is a cerebellum dependent function that can be measured with a visuomotor rotation task (VRT).

The project aims to identify a sensitive and specific biomarker of cerebellum dysfunction in chronic cannabis users. The investigators would like to demonstrate that the visuomotor rotation paradigm is valid to measure and quantify such a dysfunction.

A longitudinal prospective study with a 3 month follow-up is proposed. 3 groups will be included: 1) chronic cannabis users; 2) individuals with an alcohol use disorder; and 3) healthy controls. All groups will be matched by sex and age. Forty individuals will be included in each group. Individuals will be assessed at baseline, at first month and at 3-months of follow-up. Sociodemographic and clinical data will be recorded. Information on cannabis consumption will be registered using an App.

Participants will do the visuomotor rotation task and answer three questionnaires: the Intrinsic Motivation Inventory, the Scale for the assessment and rating of ataxia (SARA) and the Harris tests for lateral dominance.

The biomarker developed by this project will facilitate the detection of cerebellar alterations in chronic cannabis users, and will permit to quantify and monitor such alteration over time. The team's intention is to patent the proposed model and disseminate it in order to use it in clinical practice at both primary and specialized health centres.


Condition or disease Intervention/treatment
Cannabis Use Alcohol Use Disorder Healthy Diagnostic Test: Visuomotor adaptation task

Detailed Description:
The subjects have to realize movements towards a target, at a digitizing tablet, holding a digitizing pencil. Visual feedback is projected on a screen surface in front of the subject, which hides the sight of actual movements from the latter. In the experimental condition of rotation, the experimenter introduces a rotation of 45 grades between the movement realized by the subject and the visual feedback that is provided on the screen. Then, the subject is provided with a strategy in order to overcome this perturbation: that is, to make the movement aiming 45 grades to the opposite direction from the introduced rotation. This explicit strategy leads to immediate correction of the error, but as the time passes subjects tend to commit more and more errors due to implicit motor adaptation. This happens because the motor control system tends to correct the perceived perturbation between the anticipated and the actual location of the hand in an automatic and unconscious way. The conflict between the implicit and explicit strategies has the surprising consequence of a persistent and accumulative deterioration of performance that can only be resolved when the participants abandon the explicit strategy. Subjects with cerebellar damage show deficits in implicit motor learning and for this reason they do not show this progressive deterioration of performance. Given that chronic cannabis abuse can lead to cerebellar damage, the investigators hypothesize that subjects from the experimental group 1 (cannabis use) will have a significant smaller directional error on the rotation condition than controls. A second hypothesis is that this effect will be cannabis-specific, due to the high CB1R concentration on the cerebellum, so the alcohol dependence group is expected to perform similarly to control group

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Visuomotor Rotation Task as a Biomarker of Cerebellar Dysfunction in Chronic Cannabis Use
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1 -Chronic cannabis use
Individuals between 18 and 50 years old who have been using at least 2 joints per day for at least 3 years. They should have used cannabis during the last 24h but not during the 3h prior to participation to the study and they should test positive for cannabis in their urine. Individuals with another substance use or severe mental disorder will be excluded (except tobacco use)
Diagnostic Test: Visuomotor adaptation task
We will measure performance of the subjects of each group on the visuomotor adaptation task, especially in the rotation condition, in which a perturbation will be induced between the anticipated location of the hand and the provided visual feedback, and in the washout condition, in which the rotation will be removed. We expect that subjects with cannabis use disorder will not show the expected implicit motor adaptation to the perturbation and consequently no deterioration of performance on the task, due to cannabis-induced cerebellar damage. In other words, we want to show that this visuomotor task is a cheap and quick biomarker of cerebellar dysfunction in chronic cannabis users.

Group 2 - Alcohol dependence
Individuals between 18 and 50 years old diagnosed with alcohol use disorder according to DSM-V criteria and have been consuming alcohol for at least 3 years. Individuals who are diagnosed with another substance use or severe mental disorder will be excluded (except tobacco use).
Diagnostic Test: Visuomotor adaptation task
We will measure performance of the subjects of each group on the visuomotor adaptation task, especially in the rotation condition, in which a perturbation will be induced between the anticipated location of the hand and the provided visual feedback, and in the washout condition, in which the rotation will be removed. We expect that subjects with cannabis use disorder will not show the expected implicit motor adaptation to the perturbation and consequently no deterioration of performance on the task, due to cannabis-induced cerebellar damage. In other words, we want to show that this visuomotor task is a cheap and quick biomarker of cerebellar dysfunction in chronic cannabis users.

Control Group
Individuals matched in gender and age with the experimental groups and with no diagnosis of substance use or severe mental disorder (except tobacco use)
Diagnostic Test: Visuomotor adaptation task
We will measure performance of the subjects of each group on the visuomotor adaptation task, especially in the rotation condition, in which a perturbation will be induced between the anticipated location of the hand and the provided visual feedback, and in the washout condition, in which the rotation will be removed. We expect that subjects with cannabis use disorder will not show the expected implicit motor adaptation to the perturbation and consequently no deterioration of performance on the task, due to cannabis-induced cerebellar damage. In other words, we want to show that this visuomotor task is a cheap and quick biomarker of cerebellar dysfunction in chronic cannabis users.




Primary Outcome Measures :
  1. Change in directional error between baseline and after cessation of cannabis use [ Time Frame: The visuomotor adaptation task duration will not exceed 20 minutes and subjects are expected to realize it at three different time points: baseline, 1 month, 3 months ]
    Directional error of hand movement trajectories towards the target object on the rotation condition of the visuomotor rotation task.


Biospecimen Retention:   Samples Without DNA
Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The experimental group 1 (cannabis use) will consist of the patients of the Addiction Unit of Hospital Clinic that are seeking or already are in treatment for cannabis use or participants that fulfil the eligibility criteria and contact the responsible for this study investigators , after the diffusion of the study. The experimental group 2 (alcohol use) will consist of patients of the Addiction Unit of Hospital Clinic that are in treatment for alcohol dependency. The control subjects will be recruited through the public diffusion of the study.
Criteria

Inclusion Criteria:

  • 18-50 years old
  • Right-handed
  • Daily consumption of cannabis for at least 2 years (cannabis group) or diagnosed Alcohol Use Disorder (alcohol group)

Exclusion Criteria:

  • Non-corrected visual deficits
  • Regular consumption of other drugs except nicotine
  • Other Axis I or neurological diagnosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662737


Contacts
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Contact: Antoni Gual, MD,PhD +34932275400 ext 1719 TGUAL@clinic.cat

Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Antoni Gual, MD,PhD Hospital clinic Bracelona

Publications:

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Responsible Party: Antoni Gual, MD, PhD, Head of Addiction Unit, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03662737     History of Changes
Other Study ID Numbers: TRV-CAN
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antoni Gual, Hospital Clinic of Barcelona:
Visuomotor task
Additional relevant MeSH terms:
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Cerebellar Diseases
Marijuana Abuse
Alcoholism
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol-Related Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases