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Cerebral Hemodynamics With rTMS in Alcohol Dependence

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsored by
Central Institute of Psychiatry, Ranchi, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Transcranial Doppler (TCD) sonography, rTMS, Cerebral hemodynamics

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Central Institute of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Sham Comparator

Arm Label

Healthy control

Active rTMS group

Sham rTMS group

Arm Description

No Repetitive Transcranial Magnetic Stimulation (rTMS)

Active Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

Outcomes

Primary Outcome Measures

Mean velocity (MV) of middle cerebral artery (MCA) and anterior cerebral artery (ACA)

Secondary Outcome Measures

Pulsatility index (PI) of middle cerebral artery (MCA) and anterior cerebral artery (ACA)
Resistance index (RI) of middle cerebral artery (MCA) and anterior cerebral artery (ACA)

Full Information

First Posted
May 13, 2015
Last Updated
May 14, 2015
Sponsor
Central Institute of Psychiatry, Ranchi, India
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1. Study Identification

Unique Protocol Identification Number
NCT02446067
Brief Title
Cerebral Hemodynamics With rTMS in Alcohol Dependence
Official Title
Cerebral Hemodynamics With rTMS in Alcohol Dependence: A Randomized, Sham Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Institute of Psychiatry, Ranchi, India

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Alcohol abuse is a worldwide problem causing serious physical, psychological, social and economic consequences. Chronic alcohol intake has been found to increased blood viscosity, erythrocyte deformability or dehydration resulting in alterations of cerebral blood flow measures. Transcranial Doppler (TCD) sonography is a non-invasive radiological tool used for assessing the hemodynamics of the basal cerebral arteries, which can thus indirectly reflect the relative changes in regional cerebral blood flow velocity (CBFV) and vascular wall resistance. It has been used to evaluate the relative cerebral blood flow velocity changes in various psychiatric disorders like depression, schizophrenia, panic disorder, and substance use disorders including alcohol and marijuana. TCD also gives a real time assessment of the abrupt or short and long lasting effects of any external mechanical manipulation or functional stimulation of the intracranial circulation. The Mean flow velocity (MV) is the average of the edge frequency over a cardiac cycle; the edge frequency being the envelope of instantaneous peak velocities throughout the course of a cardiac cycle. Pulsatility index (PI) represents an estimate of downstream vascular resistance; low resistance vascular beds have higher diastolic flow velocities than high resistance vascular beds, hence they have low PI, and vice versa. Similarly, Resistance index (RI) is another presumptive measure of downstream vascular resistance. TCD sonography studies in alcoholism have revealed reduced mean blood flow velocities in basal cerebral arteries in chronic alcohol dependence, [1] as well as in acute stage of intoxication, but an increase after resolution of withdrawal state. [12] However, ethanol in low concentration has been found to increase the systolic, diastolic and mean blood flow velocity in middle cerebral arteries (MCA), anterior cerebral arteries (ACA) and decrease the resistance indices by reducing the cerebrovascular resistance in healthy individuals. Studies have reported that alcohol related hepatic dysfunction results in increased blood viscosity and reduced velocity in the cerebral arteries, which can be a risk factor for ischemic brain diseases. So, normalization of hemodynamic parameters is important in the prevention of possible ischemic brain diseases due to alcohol dependence. Studies evaluating cerebral hemodynamic response to rTMS application have been limited to healthy individuals, with high frequency rTMS application found to increase the cerebral blood flow velocities in both anterior and posterior basal cerebral arteries, and low frequency rTMS to temporarily decrease the blood flow velocity in ipsilateral MCA followed by an increase in the contralateral MCA. With this background, the present study was conducted to measure the cerebral hemodynamic indices of alcohol dependent patients and observe the relative changes in these parameters with rTMS application.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Transcranial Doppler (TCD) sonography, rTMS, Cerebral hemodynamics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy control
Arm Type
No Intervention
Arm Description
No Repetitive Transcranial Magnetic Stimulation (rTMS)
Arm Title
Active rTMS group
Arm Type
Active Comparator
Arm Description
Active Repetitive Transcranial Magnetic Stimulation (rTMS)
Arm Title
Sham rTMS group
Arm Type
Sham Comparator
Arm Description
Sham Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean velocity (MV) of middle cerebral artery (MCA) and anterior cerebral artery (ACA)
Time Frame
up to 5 minutes after last (10th) rTMS session
Secondary Outcome Measure Information:
Title
Pulsatility index (PI) of middle cerebral artery (MCA) and anterior cerebral artery (ACA)
Time Frame
up to 5 minutes after last (10th) rTMS session
Title
Resistance index (RI) of middle cerebral artery (MCA) and anterior cerebral artery (ACA)
Time Frame
up to 5 minutes after last (10th) rTMS session

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Central Institute of Psychiatry
City
Ranchi
State/Province
Jharkhand
ZIP/Postal Code
834006
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
11468137
Citation
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.
Results Reference
result
PubMed Identifier
11153967
Citation
Pecuch 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.
Results Reference
result
PubMed Identifier
17113598
Citation
de 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.
Results Reference
result
PubMed Identifier
1992832
Citation
Mathew 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.
Results Reference
result
PubMed Identifier
16129568
Citation
Gdovinova 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.
Results Reference
result
PubMed Identifier
12637048
Citation
Blaha 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.
Results Reference
result
PubMed Identifier
16905439
Citation
Stendel 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.
Results Reference
result
PubMed Identifier
2597811
Citation
Sullivan 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.
Results Reference
result

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Cerebral Hemodynamics With rTMS in Alcohol Dependence

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