Cocaine Use DisorderNCT03733821
Subjective Sleep Quality in CUD TMS-Treated
An observational study of Cocaine Use Disorder and Sleep Disturbance, run by Fondazione Novella Fronda at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cocaine Use Disorder, Sleep Disturbance
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Current diagnosis of CUD according to DSM-5;
Who cannot join
- 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);
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Studio Gallimberti Bonci & Partners
Padua, 35139
Graziella Madeo, MD, PhD, 0039 392 0170804, graziemadeo@gmail.com
Stefano Cardullo, PhD, 0039 340 2575589, stefano.cardullo@gmail.com
About this study
Official title: Sleep Modifications in Patients With Cocaine Use Disorders Treated With Transcranial Magnetic Stimulation (TMS)
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).
Read the detailed description
Cocaine use disorder (CUD) is a chronic relapsing brain disorder characterized by a problematic pattern of cocaine consumption leading to a clinically significant impairment. A core element of this disease is the increased vulnerability to relapse during the first weeks of abstinence. Commonly withdrawal symptoms as sleep disturbances, negative affect or craving, may contributes critically to relapses. Especially, sleep disruptions are frequently referred by CUD individuals during either use or abstinence. Moreover, polysomnographic (PSG) data demonstrate a worsening sleep during the first weeks of abstinence in chronic cocaine users, with diminishing rapid eye movement sleep (REM) time, reduction of total sleep time, increasing sleep latency, and chronically decreased slow-wave sleep (SWS) time. Such sleep anomalies appear to be durable and relate to the severity of withdrawal symptoms and clinical outcomes in the treatment of CUD. However, causality between sleep disturbances and CUD has not been clearly established yet. Interestingly, sleep deprivation and addictive substances have comparable neurobiological effects on several neurotransmitter pathways, particularly in the dopaminergic system. Therefore, the implementation of strategies to rewire the altered brain circuits might induce clinically significant improvements of addictive symptoms and the regulation of sleep patterns in CUD patients.
Recently, transcranial magnetic stimulation (TMS), an innovative and safe brain stimulation procedure, which induce neural electrical activity through the application of magnetic pulses over the scalp and with enduring effects on mood, has been applied as a promising therapeutic approach in addictive disorders. In fact, clinical pilot studies on CUD are giving preliminary support to the potential role of rTMS in decreasing cocaine craving and use. PSG studies in healthy volunteers have shown rTMS-induced changes in sleep architecture that are opposites to those found in CUD subjects, as a prolongation of REM latency or a marked increase in slow-wave sleep. The promising therapeutic effect of TMS on insomnia, restless legs syndrome and on sleep disturbances associated to epilepsy, depression and post-traumatic stress disorder has also been suggested. Further, rTMS application over DLPFC have revealed positives outcomes in patients with chronic primary insomnia, by reducing sleep latency, increasing the total sleep time and REM latency.
These findings suggest that rTMS might impact brain circuitry, modulating relevant functions as sleep architecture and potentially affecting addictive related symptoms as craving or negative affect.
The hypothesis of the present study is that rTMS treatment intervention might have a beneficial effect on sleep disturbances reported by CUD patients during the abstinence/withdrawal period. The investigators hypothesized also the positive outcome on accompanied cocaine withdrawal symptoms (as craving or mood) of rTMS.
Hence, the aims of the present study are:
- to verify whether rTMS of the left DLPFC in CUD patients produces modifications on the subjective sleep quality patterns and drug use variables.
- to further strengthen the results of previous CUD-TMS research, the investigators will test whether rTMS of the left DLPFC in CUD patients is safe and reduces cocaine use.
Procedures:
Patients with CUD will be evaluated for sleep disturbances, craving, depression, anxiety and other clinical symptoms by completing the following scales: Pittsburgh Sleep Quality Index (PSQI), Cocaine Craving Questionnaire (CCQ), Beck Depression Inventory-II (BDI-II), Self-rating Anxiety Scale (SAS), Alcohol Use Disorders Identification Test (AUDIT) and Symptoms checklist 90 - Revised (SCL-90-R). Participants could be undergo a battery of cognitive tests such as Wisconsin Card Sorting Test (WCST), Stop Signal Task (SST), Iowa Gambling Task (IGT), Stroop task or Delay Discounting Task (DDT). The pattern of drug use will be also monitored by recording drug use variables. The measures will be assessed before the rTMS treatment (baseline), and after 5 (Day 5), 30 (Day 30), 60 (Day 60) and 90 (Day 90) days during the treatment.
- Conditions
- Cocaine Use Disorder, Sleep Disturbance
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- rTMS
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Non-invasive brain stimulation tool
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Self-reported craving will be assessed by Cocaine Craving Questionnaire (CCQ) which is a 5-item self-report questionnaire measuring five aspects of craving: current intensity, intensity during the previous 24 h, frequency, responsiveness to drug-related conditioned stimuli, and imagined likelihood of use if in a setting with access to drugs. Each craving aspects yields a score ranging from 0 to 9 with the highest values indicating high craving. The overall score is obtained by summing every item score and dividing it by 5. A higher mean craving score is associated with less likeliness to initiate abstinence.
Measured: 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
Depression symptoms will be assessed by Beck Depression Inventory - II (BDI - II) which is a 21-question multiple-choice self-report inventory with four options under each item, ranging from not present (0) to severe (3), measuring depressive symptoms. This inventory scoring is obtained by summing the highest ratings for each of the 21 items, with a sum scores range from 0 to 63. The severity levels suggested in the manual are the following: Scores between 0 and 13 indicate minimal, between 14 and 19 mild, between 20 and 28 moderate, and between 29 and 63 severe depression.
Measured: 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
Anxiety symptoms will be assessed by Self-rating Anxiety Scale (SAS) which is is a 20-item measure developed to assess the frequency of anxiety symptoms based on diagnostic conceptualizations. It consists primarily of somatic symptoms. Each symptom is rated on a 4-point Likert scale on frecuency basis from 1 ('"none or a little of the time'") to 4 ('"most or all of the time''). Items 5, 9, 13, 17, and 19 are reversed scored and total scores on the SAS range from 0 to 80, with higher scores indicating more frequents anxiety symptoms.
Measured: 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
Subjective symptoms of mental disorder will be assessed by Symptoms checklist 90 - Revised (SCL-90-R) which is is a 90-item self-report inventory which assesses psychological distress in terms of nine primary symptom dimensions and three summary scores termed global scores. Each item describes a physical or psychological symptomthat is rated on a five-point scale ranging from 1 (not at all) to 5 (extremely). The Global Severity Index (GSI) is the single best indicator of the current level or depth of an individual's disorder. It combines information concerning the number of symptoms reported with the intensity of perceived distress.
Measured: 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
Cocaine intake will be determined determined either via a urine drug test or referral reported relapse
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study startJan 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Novella Fronda
- Sponsor type
- University, hospital or other
- Collaborators
- Studio Gallimberti Bonci & Partners
- Responsible party
- Sponsor
- Investigators
- Michela Sarlo, Assoc. Prof., Principal investigator, Department of General Psychology, University of PadovaNicola Cellini, PhD, Study chair, Department of General Psychology, University of PadovaStefano Cardullo, PhD, Study chair, Fondazione Novella Fronda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733821
- Sponsor's protocol ID
- SL33P0NCUDTM2TR34T3D
- Status last verified
- Feb 2020
- First submitted
- 6 Nov 2018
- Last updated
- 13 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32252720
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Modifications in Patients With Cocaine Use Disorders Treated With Transcranial Magnetic Stimulation (TMS)
- ClinicalTrials.gov ID
- NCT03733821
- Acronym / sponsor ID
- SL33P0NCUDTM2TR34T3D
- Conditions
- Cocaine Use Disorder, Sleep Disturbance
- Keywords
- rTMS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fondazione Novella FrondaUniversity, hospital or other
- Collaborators
- Studio Gallimberti Bonci & Partners
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Cocaine use disorder (CUD) is a chronic relapsing brain disorder characterized by a problematic pattern of cocaine consumption leading to a clinically significant impairment. A core element of this disease is the increased vulnerability to relapse during the first weeks of abstinence. Commonly withdrawal symptoms as sleep disturbances, negative affect or craving, may contributes critically to relapses. Especially, sleep disruptions are frequently referred by CUD individuals during either use or abstinence. Moreover, polysomnographic (PSG) data demonstrate a worsening sleep during the first weeks of abstinence in chronic cocaine users, with diminishing rapid eye movement sleep (REM) time, reduction of total sleep time, increasing sleep latency, and chronically decreased slow-wave sleep (SWS) time. Such sleep anomalies appear to be durable and relate to the severity of withdrawal symptoms and clinical outcomes in the treatment of CUD. However, causality between sleep disturbances and CUD has not been clearly established yet. Interestingly, sleep deprivation and addictive substances have comparable neurobiological effects on several neurotransmitter pathways, particularly in the dopaminergic system. Therefore, the implementation of strategies to rewire the altered brain circuits might induce clinically significant improvements of addictive symptoms and the regulation of sleep patterns in CUD patients.
Recently, transcranial magnetic stimulation (TMS), an innovative and safe brain stimulation procedure, which induce neural electrical activity through the application of magnetic pulses over the scalp and with enduring effects on mood, has been applied as a promising therapeutic approach in addictive disorders. In fact, clinical pilot studies on CUD are giving preliminary support to the potential role of rTMS in decreasing cocaine craving and use. PSG studies in healthy volunteers have shown rTMS-induced changes in sleep architecture that are opposites to those found in CUD subjects, as a prolongation of REM latency or a marked increase in slow-wave sleep. The promising therapeutic effect of TMS on insomnia, restless legs syndrome and on sleep disturbances associated to epilepsy, depression and post-traumatic stress disorder has also been suggested. Further, rTMS application over DLPFC have revealed positives outcomes in patients with chronic primary insomnia, by reducing sleep latency, increasing the total sleep time and REM latency.
These findings suggest that rTMS might impact brain circuitry, modulating relevant functions as sleep architecture and potentially affecting addictive related symptoms as craving or negative affect.
The hypothesis of the present study is that rTMS treatment intervention might have a beneficial effect on sleep disturbances reported by CUD patients during the abstinence/withdrawal period. The investigators hypothesized also the positive outcome on accompanied cocaine withdrawal symptoms (as craving or mood) of rTMS.
Hence, the aims of the present study are:
- to verify whether rTMS of the left DLPFC in CUD patients produces modifications on the subjective sleep quality patterns and drug use variables.
- to further strengthen the results of previous CUD-TMS research, the investigators will test whether rTMS of the left DLPFC in CUD patients is safe and reduces cocaine use.
Procedures:
Patients with CUD will be evaluated for sleep disturbances, craving, depression, anxiety and other clinical symptoms by completing the following scales: Pittsburgh Sleep Quality Index (PSQI), Cocaine Craving Questionnaire (CCQ), Beck Depression Inventory-II (BDI-II), Self-rating Anxiety Scale (SAS), Alcohol Use Disorders Identification Test (AUDIT) and Symptoms checklist 90 - Revised (SCL-90-R). Participants could be undergo a battery of cognitive tests such as Wisconsin Card Sorting Test (WCST), Stop Signal Task (SST), Iowa Gambling Task (IGT), Stroop task or Delay Discounting Task (DDT). The pattern of drug use will be also monitored by recording drug use variables. The measures will be assessed before the rTMS treatment (baseline), and after 5 (Day 5), 30 (Day 30), 60 (Day 60) and 90 (Day 90) days during the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CUD patients on HF-rTMS treatment | – | Device: Repetitive Transcranial Magnetic StimulationPatients 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Current diagnosis of CUD according to DSM-5;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationNon-invasive brain stimulation tool | Device | CUD patients on HF-rTMS treatment |
Primary outcome
High frequency rTMS effects on subjective sleep quality in CUD patients
Time frame: 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)
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.
5 secondary outcomes
High frequency rTMS effects on self-reported craving in CUD patients
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Derived from this study: PubMed 32252720Gomez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michela Sarlo, Assoc. Prof. principal investigator
Department of General Psychology, University of Padova
Nicola Cellini, PhD study chair
Department of General Psychology, University of Padova
Stefano Cardullo, PhD study chair
Fondazione Novella Fronda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cocaine Use Disorder and Sleep Disturbance, run by Fondazione Novella Fronda at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Graziella Madeo, MD, PhD (0039 3920170804, graziemadeo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High frequency rTMS effects on subjective sleep quality in CUD patients (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03733821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.