Repetitive Transcranial Magnetic Stimulation (rTMS) of the Insula for Treatment of Alcohol Addiction

NCT02643264 | Unknown DMC

• 1 other identifier: LIU2015/130-31
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) targeting the insula on alcohol use and neural responses in alcohol-dependent patients.

Conditions

Alcohol Addiction

Keywords

insula; alcohol addiction; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (2)

• Heavy Drinking

  Reduction in heavy alcohol use during the outpatient follow-up phase (%heavy drinking days) measured by standard Time-Line Follow-Back methodology

  12 weeks follow-up from treatment completion

• Insula activity

  Insula activity (%signal change, as measured by fMRI BOLD), during a task known to be associated with insula responses, risky decision making

  Within 5 days of treatment completion

Secondary Outcomes (5)

• BOLD responses in a battery of standard fMRI tasks that probe processing of alcohol-associated cues, reward function, and emotional responses.

  Within 5 days after the last TMS session

• Alterations in resting-state connectivity of the insula with other nodes in the putative Salience Network (SN), executive control network (ECN) and the default-mode network (DMN) by rTMS.

  Within 5 days after the last TMS session

• Objective biomarkers of alcohol use

  12 weeks follow-up from treatment completion

• Alcohol craving and psychiatric symptoms

  12 weeks follow-up from treatment completion

• Smoking

  12 weeks follow-up from treatment completion

Study Arms (2)

rTMS 10 Hz

EXPERIMENTAL

Deep Repetitive Transcranial Magnetic Stimulation (rTMS, 10 Hz) of the insula ,15 stimulation sessions (1 daily, 5 days / week).

Other: rTMS 10 Hz targeting the insula

rTMS Sham

SHAM COMPARATOR

Sham Repetitive Transcranial Magnetic Stimulation (rTMS, Sham),15 stimulation sessions (1 daily, 5 days / week).

Other: Sham rTMS

Interventions

rTMS 10 Hz targeting the insula OTHER

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 10 Hz

Sham rTMS OTHER

Sham stimulation with the same regimen as active treatment

rTMS Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 65
• Current Diagnostic and Statistical Manual (DSM-IV-TR) diagnosis of alcohol dependence
• Alcohol use in the past month
• Right handed (self-report)
• If female, negative urine pregnancy test
• 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

You may not qualify if:

• Currently pregnant or breastfeeding
• More than mild cognitive impairment, as determined by a score on the Mini Mental State Examination (MMSE) \<24.
• Current DSM-IV diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder
• 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
• 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).
• Any history of seizures other than febrile childhood seizures (self-reported history)
• Signs of increased intracranial pressure as determined by the structural MRI-scan
• Clinically significant hearing impairment or tinnitus
• 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.
• Cannot recline comfortably flat on his/her back for up to 2 hours in the MRI scanner.
• 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.

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Linkoping University

Linköping, 581 85, Sweden

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Markus A Heilig, MD PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Markus A Heilig, MD, PhD

CONTACT

+46 13286626; markus.heilig@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: December 31, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 31, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)