Subjective Sleep Quality in CUD TMS-Treated

NCT03733821 | Unknown

• 1 other identifier: SL33P0NCUDTM2TR34T3D
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep disruptions are prevalent complaints in cocaine use disorder (CUD) subjects, either during consumption or withdrawal. Repetitive transcranial magnetic stimulation (rTMS) seem to be a promissing strategy in the treatment of chronic cocaine users. The aim of this study will be to assess the variation on self-perceived sleep quality and drug use variables in individuals with CUD undergoing a rTMS protocol over the left dorsolateral prefrontal cortex (DLPFC).

Conditions

Cocaine Use Disorder; Sleep Disturbance

Keywords

rTMS

Outcome Measures

Primary Outcomes (1)

• High frequency rTMS effects on subjective sleep quality in CUD patients

  The subjective sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI). This scale is composed by 19 items clustered into 7 components, including sleep duration, sleep disturbance, sleep latency, daytime dysfunction, sleep efficiency, overall sleep quality, and sleep medication use. Each of them generates a score ranging from 0 to 3, with the highest value indicating the greatest dysfunction. The sleep component scores are summed to produce a global score ranging from 0 to 21 with the higher score indicating worse sleep quality. A global score higher than 5 is considered an indicator of relevant sleep disturbances.

  Baseline- Day 5 (after 10 rTMS sessions)- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)

Secondary Outcomes (5)

• High frequency rTMS effects on self-reported craving in CUD patients

  Baseline- Day 5 (after 10 rTMS sessions)- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)

• High frequency rTMS effects on Depression Symptoms in CUD patients

  Baseline- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)

• High frequency rTMS effects on Anxiety Symptoms in CUD patients

  Baseline- Day 5 (after 10 rTMS sessions)- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)

• High frequency rTMS effects on subjective symptoms of mental disorder in CUD patients

  Baseline- Day 5 (after 10 rTMS sessions)- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)

• High frequency rTMS effects on cocaine intake

  Baseline- Day 5 (after 10 rTMS sessions)- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)

Study Arms (1)

CUD patients on HF-rTMS treatment

Patients fulfilling the Diagnostic and Statistical Manual of Mental Disorders - 5 (DSM 5) criteria for Cocaine Use Disorder undergoing a High Frequency rTMS protocol stimulating over the left dorsolateral prefrontal cortex (DLPFC).

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

Non-invasive brain stimulation tool

CUD patients on HF-rTMS treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants recruited after referral to specialty outpatient clinic Center for Addiction and meeting diagnostic criteria for Cocaine Use Disorder according to the Diagnostic and Statistical Manual of Mental Disorders - 5 (DSM 5), as assessed by an SUDs expert clinical psychiatrist.

You may qualify if:

• \- Current diagnosis of CUD according to DSM-5;

You may not qualify if:

• Pregnancy or breastfeeding;
• Current DSM-5 diagnosis for Schizophrenia Spectrum and Other Psychotic Disorders, Major Depressive Disorder or Bipolar and Related Disorders;
• Current DSM-5 diagnosis for Alcohol and Substance use disorders (except Tobacco use disorders);
• Current DSM-5 diagnosis for Personality disorders;
• Current DSM-5 diagnosis for Primary Sleep-Wake Disorders;
• Prior history of un unstable medical illness, substantial neurological illness, any contraindication for rTMS (including implanted metal and devices in the body, and history of epilepsy);

Sponsors & Collaborators

• Fondazione Novella Fronda: lead
• Studio Gallimberti Bonci & Partners: collaborator

Study Sites (1)

Studio Gallimberti Bonci & Partners

Padua, 35139, Italy

RECRUITING

Related Publications (1)

• Gomez Perez LJ, Cardullo S, Cellini N, Sarlo M, Monteanni T, Bonci A, Terraneo A, Gallimberti L, Madeo G. Sleep quality improves during treatment with repetitive transcranial magnetic stimulation (rTMS) in patients with cocaine use disorder: a retrospective observational study. BMC Psychiatry. 2020 Apr 6;20(1):153. doi: 10.1186/s12888-020-02568-2.

  PMID: 32252720 DERIVED

MeSH Terms

Conditions

Parasomnias

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Michela Sarlo, Assoc. Prof.

  Department of General Psychology, University of Padova

  PRINCIPAL INVESTIGATOR

• Nicola Cellini, PhD

  Department of General Psychology, University of Padova

  STUDY CHAIR

• Stefano Cardullo, PhD

  Fondazione Novella Fronda

  STUDY CHAIR

Central Study Contacts

Graziella Madeo, MD, PhD

CONTACT

0039 3920170804; graziemadeo@gmail.com

Luis J Gómez Pérez, MSc

CONTACT

0039 3286086304; luigomper@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 7, 2018
• Study Start: January 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

IT (1)