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Alcohol DependenceNCT02446067

Cerebral Hemodynamics With rTMS in Alcohol Dependence

A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Alcohol Dependence, run by Central Institute of Psychiatry, Ranchi, India at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The present study measures the cerebral hemodynamic indices of alcohol dependent patients and observe the relative changes in these parameters with rTMS application. Read more about this study

Who is it for?
Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for
Alcohol Dependence
What is being tested?
Repetitive Transcranial Magnetic Stimulation (rTMS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
1 siteIndia
Study dates
Mar 2010to May 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

India1 site

  • Central Institute of Psychiatry

    Ranchi, Jharkhand, 834006

Other trials in India

About this study

Official title: Cerebral Hemodynamics With rTMS in Alcohol Dependence: A Randomized, Sham Controlled Study

The present study measures the cerebral hemodynamic indices of alcohol dependent patients and observe the relative changes in these parameters with rTMS application.

Read the 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.

Being tested
Repetitive Transcranial Magnetic Stimulation (rTMS)
Keywords
Transcranial Doppler (TCD) sonography, rTMS, Cerebral hemodynamics
Medical subject headings
Alcoholism, Choroideremia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Repetitive Transcranial Magnetic Stimulation (rTMS)Device

    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.

Study groups in NCT02446067
Study groupRoleWhat they receive
Healthy controlNo interventionNo Repetitive Transcranial Magnetic Stimulation (rTMS)
Active rTMS groupActive comparatorActive Repetitive Transcranial Magnetic Stimulation (rTMS)
Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham rTMS groupSham comparatorSham Repetitive Transcranial Magnetic Stimulation (rTMS)
Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: up to 5 minutes after last (10th) rTMS session

Secondary outcomes (2)

  1. Pulsatility index (PI) of middle cerebral artery (MCA) and anterior cerebral artery (ACA)

    Measured: up to 5 minutes after last (10th) rTMS session

  2. Resistance index (RI) of middle cerebral artery (MCA) and anterior cerebral artery (ACA)

    Measured: up to 5 minutes after last (10th) rTMS session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2015 (estimated)
  2. Study startMar 2010
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02446067
Sponsor's protocol ID
CIPRanchi
Status last verified
May 2015
First submitted
13 May 2015
Last updated
15 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 11468137

  • 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.

    PubMed 11153967

  • 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.

    PubMed 17113598

  • 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.

    PubMed 1992832

  • 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.

    PubMed 16129568

  • 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.

    PubMed 12637048

  • 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.

    PubMed 16905439

  • 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.

    PubMed 2597811

Questions about this trial

What is this clinical trial studying?

A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Alcohol Dependence, run by Central Institute of Psychiatry, Ranchi, India at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean velocity (MV) of middle cerebral artery (MCA) and anterior cerebral artery (ACA) (time frame: up to 5 minutes after last (10th) rTMS session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02446067, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2015.

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