None listed
Conditions
Brief summary
Alcohol craving may be a major factor in why some patients with severe alcoholism can't stop drinking, or relapse after a period of abstinence. This craving may be caused by abnormally increased activation of a part of the brain (the anterior cingulate cortex). It may be possible to suppress craving and thus help abstinence from alcohol, by using neuromodulation methods. Initially we would identify patients who have reduced craving in response to transcranial magnetic stimulation of this brain area. Patients could then have an electrode implanted that could help maintain long-term abstinence from alcohol, and may also potentially help improve symptoms of depression and anxiety.
Interventions
A laterolateral frontal incision is made followed by a 4 cm x 4 cm right frontal craniotomy crossing the superior sagittal sinus. The dura is incised and two Lamitrode 44 electrodes (St Jude Medical, Plano, Dallas, TX) are placed interhemispherically, touching the rostral anterior cingulate cortices. This surgery may take ~2 hours.
Electrodes will be activated on Day 3 or Day 17 in a blinded manner. Stimulation patterns will be optimized over 1 week, initially with a 3 Hz burst stimulation wit
A laterolateral frontal incision is made followed by a 4 cm x 4 cm right frontal craniotomy crossing the superior sagittal sinus. The dura is incised and two Lamitrode 44 electrodes (St Jude Medical, Plano, Dallas, TX) are placed interhemispherically, touching the rostral anterior cingulate cortices. This surgery may take ~2 hours. Electrodes will be activated on Day 3 or Day 17 in a blinded manner. Stimulation patterns will be optimized over 1 week, initially with a 3 Hz burst stimulation with 5 spikes at 500 Hz in cycle mode (5 seconds on, 5 seconds off). The stimulation design can be individually adjusted to further optimize the anticraving effect. This might include burst or spike frequency adjustment, or switching to a noise-like pattern. Electrodes will remain in place permanently.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Capable of understanding and signing an informed consent 2. Meeting DSM-5 severe Alcohol Use Disorder, based on a structured clinical interview with a consultant psychiatrist. 3. Primary addiction is to alcohol 4. Scoring >7 on the obsessive compulsive drinking scale. 5. Patients must have failed to respond to at least one residential alcohol treatment programme, at least one anticraving medication, and at least one outpatient intervention with specialist alcohol services. 6. Patients must be seeking help for their alcohol use disorder, and be willing to cooperate with surgical and psychiatric follow up. 7. Patients may remain on antidepressant or antianxiety medication during the study, but drugs and doses must remain unchanged from 6 weeks prior to surgery until 12 weeks post-surgery. 8. Patients must have a supportive social network (minimum 1 person) that they will provide contact details for, and involve in pre-/post-surgery appointments. 9. Patients must respond to rTMS with reduced alcohol craving (>50% reduction in craving numeric rating scale), using blinded placebo controlled testing
Exclusion criteria
1. History of epileptic seizures (except those associated with alcohol withdrawal) 2. Psychiatric disorders with psychotic symptoms or manic symptoms 3. Patients with pace makers/defibrillators 4. Patients who have contraindications for MRI 5. Female patients who are or intend to become pregnant 6. Participants who, in the opinion of the investigator, do not understand the information and procedures of the study, or would not be compliant with them (in particular the study restrictions and risks involved). 7. Any participant for whom the investigator believes, for any reason, that participation would not be an acceptable risk.
Outcome results
None listed