Repetitive Transcranial Magnetic Stimulation (rTMS) of the Insula for Treatment of Alcohol Addiction
NCT ID: NCT02643264
Last Updated: 2015-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
84 participants
INTERVENTIONAL
2015-11-30
2017-12-31
Brief Summary
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Detailed Description
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Study population: Treatment seeking alcohol dependent subjects (N=82), aged 18-65 years, who have first completed standard alcohol withdrawal treatment if needed.
Design: This is a double-blind, sham-controlled randomized study, comprising three phases. Participants will be hospitalized during the first two of these, and will be outpatients during the third. During Phase 1 the study (screening; up to 14 days), participants will undergo a set of baseline assessments; this phase will conclude with consent, inclusion and randomization. During Phase 2 (treatment; appr. 3 weeks, with at least the first week being hospitalized), participants will first undergo an MRI scan to collect resting state and structural data, and will then receive one of two treatments: Active (10Hz) rTMS; or sham stimulation, both targeting the insula bilaterally. rTMS sessions will be conducted five times per week, for 3 weeks, for a total of 15 sessions. Stimulation will be with an H-coil designed to reach deeper structures such as the insula. A second MRI scan will be obtained at the end of this phase to assess changes in resting state connectivity, and to evaluate insula activity in tasks known to activate this structure. In addition, a lumbar puncture will be carried out at the end of this phase to assess possible effects on central neurotransmitter and growth factor levels, as indexed in the cerebrospinal fluid. For Phase 3 (follow-up, lasting 12 weeks), patients will be followed as outpatients for 12 weeks, with clinic visits at weeks 1, 2, 4, 8 and 12 post discharge; measures of alcohol use will be collected during this phase.
Outcome measures: The co-primary outcome measures will be heavy alcohol consumption during the follow-up phase, assessed using time-line follow-back methodology; and insula BOLD functional magnetic resonance imaging (fMRI) responses during tasks known to induce insula activation. A number of secondary and exploratory measures will also be assessed, including objective biomarkers of alcohol consumption.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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rTMS 10 Hz
Deep Repetitive Transcranial Magnetic Stimulation (rTMS, 10 Hz) of the insula ,15 stimulation sessions (1 daily, 5 days / week).
rTMS 10 Hz targeting the insula
Participants will receive a total of 15 sessions of rTMS targeting the insula bilaterally, Stimulation will be delivered at an intensity of 120% of the motor threshold (MT), with a frequency of 10 Hz, delivered as 50 trains of 30 pulses delivered in each train of 3 seconds duration, with a 20 seconds inter-train interval, for a total of 1500 pulses delivered over app. 20 min. On the very first two sessions stimulations will be given at lower strength for adaptation, starting at 100% for the first and 110% for the second session
rTMS Sham
Sham Repetitive Transcranial Magnetic Stimulation (rTMS, Sham),15 stimulation sessions (1 daily, 5 days / week).
Sham rTMS
Sham stimulation with the same regimen as active treatment
Interventions
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rTMS 10 Hz targeting the insula
Participants will receive a total of 15 sessions of rTMS targeting the insula bilaterally, Stimulation will be delivered at an intensity of 120% of the motor threshold (MT), with a frequency of 10 Hz, delivered as 50 trains of 30 pulses delivered in each train of 3 seconds duration, with a 20 seconds inter-train interval, for a total of 1500 pulses delivered over app. 20 min. On the very first two sessions stimulations will be given at lower strength for adaptation, starting at 100% for the first and 110% for the second session
Sham rTMS
Sham stimulation with the same regimen as active treatment
Eligibility Criteria
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Inclusion Criteria
2. Current Diagnostic and Statistical Manual (DSM-IV-TR) diagnosis of alcohol dependence
3. Alcohol use in the past month
4. Right handed (self-report)
5. If female, negative urine pregnancy test
6. If female, must either agree to practice an effective birth control method; have a partner with a vasectomy; agree to abstinence from intercourse; be surgically sterile or postmenopausal for at least one year
Exclusion Criteria
2. More than mild cognitive impairment, as determined by a score on the Mini Mental State Examination (MMSE) \<24.
3. Current DSM-IV diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder
4. Use in the past 4 weeks of any medication or illicit drug listed as being associated with "a strong potential hazard for application of rTMS due to their significant seizure threshold lowering potential" by the international consensus guidelines for delivery of TMS \[104\], as self-reported, or detected using urine toxicology screening
5. Any history of clinically significant neurological disorders, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery or personal history of head trauma that resulted in loss of consciousness for \> 5 minutes and retrograde amnesia for \> 30 minutes (self-reported history).
6. Any history of seizures other than febrile childhood seizures (self-reported history)
7. Signs of increased intracranial pressure as determined by the structural MRI-scan
8. Clinically significant hearing impairment or tinnitus
9. Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces. Eligibility will be determined by the "MRI Safety Screening Questionnaire" (see Appendix 1) and verified, if necessary, by a radiology consultant.
10. Cannot recline comfortably flat on his/her back for up to 2 hours in the MRI scanner.
11. Any psychiatric, medical or social condition whether or not listed above, due to which, in the judgment of the investigators and after any consults if indicated, participation in the study is not in the best interest of the patient.
18 Years
65 Years
ALL
No
Sponsors
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Linkoeping University
OTHER_GOV
Responsible Party
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Markus Heilig
Professor
Principal Investigators
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Markus A Heilig, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Linkoeping University
Locations
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Linkoping University
Linköping, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Asa Axén, Nurse
Role: primary
Other Identifiers
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LIU2015/130-31
Identifier Type: -
Identifier Source: org_study_id