Cerebral Hemodynamics With rTMS in Alcohol Dependence
1 other identifier
interventional
75
1 country
1
Brief Summary
The present study measures the cerebral hemodynamic indices of alcohol dependent patients and observe the relative changes in these parameters with rTMS application.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
May 15, 2015
CompletedMay 15, 2015
May 1, 2015
1.2 years
May 13, 2015
May 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean velocity (MV) of middle cerebral artery (MCA) and anterior cerebral artery (ACA)
up to 5 minutes after last (10th) rTMS session
Secondary Outcomes (2)
Pulsatility index (PI) of middle cerebral artery (MCA) and anterior cerebral artery (ACA)
up to 5 minutes after last (10th) rTMS session
Resistance index (RI) of middle cerebral artery (MCA) and anterior cerebral artery (ACA)
up to 5 minutes after last (10th) rTMS session
Study Arms (3)
Healthy control
NO INTERVENTIONNo Repetitive Transcranial Magnetic Stimulation (rTMS)
Active rTMS group
ACTIVE COMPARATORActive Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham rTMS group
SHAM COMPARATORSham Repetitive Transcranial Magnetic Stimulation (rTMS)
Interventions
The motor threshold for the left abductor pollicis brevis was determined using a figure-of-eight-shaped coil at 1 Hz frequency. Ten (over 2 weeks) rTMS sessions were administered over the right dorsolateral prefrontal cortex with an air-cooled figure-of-eight coil, angled tangentially to the head. At right DLPFC, active high-frequency (10 Hz) stimulation was administered for 4.9 seconds per train, with inter-train interval of 30 seconds, and a total of 20 trains per session. Each patient received 1000 pulses per day. The sham group was administered rTMS with the same parameters, but using a figure-of-eight sham coil.
Eligibility Criteria
You may qualify if:
- Right handed, male patients, aged between 18-60 years, with diagnosis of alcohol dependence according to DSM-IV TR, after resolution of withdrawal symptoms i.e. having Clinical Institute of Withdrawal Assessment in Alcohol Withdrawal (CIWA-Ar) score of ≤10, were included in the study.
You may not qualify if:
- Patients with comorbid psychiatric, major medical or neurological disorders or with a pacemaker or metal in any part of the body were excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Central Institute of Psychiatry
Ranchi, Jharkhand, 834006, India
Related Publications (8)
Gdovinova Z. Blood flow velocity in the middle cerebral artery in heavy alcohol drinkers. Alcohol Alcohol. 2001 Jul-Aug;36(4):346-8. doi: 10.1093/alcalc/36.4.346.
PMID: 11468137RESULTPecuch PW, Evers S, Folkerts HW, Michael N, Arolt V. The cerebral hemodynamics of repetitive transcranial magnetic stimulation. Eur Arch Psychiatry Clin Neurosci. 2000;250(6):320-4. doi: 10.1007/s004060070007.
PMID: 11153967RESULTde Castro AG, Bajbouj M, Schlattmann P, Lemke H, Heuser I, Neu P. Cerebrovascular reactivity in depressed patients without vascular risk factors. J Psychiatr Res. 2008 Jan;42(1):78-82. doi: 10.1016/j.jpsychires.2006.10.001. Epub 2006 Nov 20.
PMID: 17113598RESULTMathew RJ, Wilson WH. Substance abuse and cerebral blood flow. Am J Psychiatry. 1991 Mar;148(3):292-305. doi: 10.1176/ajp.148.3.292.
PMID: 1992832RESULTGdovinova Z. Cerebral blood flow velocity and erythrocyte deformability in heavy alcohol drinkers at the acute stage and two weeks after withdrawal. Drug Alcohol Depend. 2006 Feb 28;81(3):207-13. doi: 10.1016/j.drugalcdep.2005.07.006. Epub 2005 Aug 29.
PMID: 16129568RESULTBlaha M, Aaslid R, Douville CM, Correra R, Newell DW. Cerebral blood flow and dynamic cerebral autoregulation during ethanol intoxication and hypercapnia. J Clin Neurosci. 2003 Mar;10(2):195-8. doi: 10.1016/s0967-5868(02)00126-1.
PMID: 12637048RESULTStendel R, Irnich B, al Hassan AA, Heidenreich J, Pietilae T. The influence of ethanol on blood flow velocity in major cerebral vessels. A prospective and controlled study. Alcohol. 2006 Apr;38(3):139-46. doi: 10.1016/j.alcohol.2006.06.005. Epub 2006 Jul 28.
PMID: 16905439RESULTSullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7. doi: 10.1111/j.1360-0443.1989.tb00737.x.
PMID: 2597811RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior resident
Study Record Dates
First Submitted
May 13, 2015
First Posted
May 15, 2015
Study Start
March 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
May 15, 2015
Record last verified: 2015-05