The Role of Sympatho-vagal Balance on Different Limbs of Pain Perception in Healthy Subjects

NCT01621620 | Unknown

• 1 other identifier: TASMC-12-JG-0044-CTIL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

objectives

1. 1.To study the sympatho-vagal balance effect on different limbs of pain perception.
2. 2.To determine whether it is the hypertension by itself or the baroreflex activation due to blood pressure rise that is responsible for the analgesic effect of acute hypertension.
3. 3.Does sympatho-vagal balance influence pain perception?
4. 4.Does sympatho-vagal balance influence diffuse noxious inhibitory control systems?
5. 5.Does sympatho-vagal balance influence temporal summation?
6. 6.Does the hypoalgesic effect to acute increase in blood pressure a result of baroreflex activation?

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• The role of sympatho-vagal balance on different limbs of pain perception in healthy subjects

  The outcome will be the respose to tonic heat pain on a VAS scale from 0-100 (where 0 no pain and 100 worst pain imagined) before and after administration of drugs that afect the sympathetic nervous system.

Study Arms (1)

yohimbin

EXPERIMENTAL

Drug: Yohimbine

Interventions

Yohimbine DRUG

yohimbin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females with no known medical conditions, neither taking any chronic medications.
• Ages between 20-50.
• Capable of reading and signing an informed consent.

You may not qualify if:

• Any known former medical condition by history affecting any system in the body:
• cardiovascular - any history of angina or chest pain, known valvular disease, known arrhythmia of any kind in the past.
• hypertension defined as SBP \> 130 DBP \> 90 and heart rate at rest \> 90 BPM.
• any occlusive peripheral vascular disease (lower limbs' pulses TP, DP, popliteal and femoral pulses absence on physical examination on the first session).
• smoking.
• History of allergy to any drug.
• Inability to understand the experiment procedure and sign an informed consent.
• Any history of severe trauma trauma to the limbs.
• Any history of neurologic or psychiatric disorder.
• Pregnancy or on anticonceptive pills.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center, Pain Medicine Unit

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Pain

Interventions

Yohimbine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Giris jacob, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lior Dayan, M.D

CONTACT

972-50-4051014; liordayan.3105@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2012
• First Posted: June 18, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2014
• Last Updated: June 18, 2012

Record last verified: 2012-06

Locations

IL (1)