Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT01621620
Status:
UNKNOWN
Last Update Posted:
2012-06-18
First Post:
2012-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Sympatho-vagal Balance on Different Limbs of Pain Perception in Healthy Subjects
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Study Overview
Official Title:
The Role of Sympatho-vagal Balance on Different Limbs of Pain Perception in Healthy Subjects
Status:
UNKNOWN
Status Verified Date:
2012-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
objectives
1. To study the sympatho-vagal balance effect on different limbs of pain perception.
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.
study questions
The study questions are derived from the study objectives:
1. Does sympatho-vagal balance influence pain perception?
2. Does sympatho-vagal balance influence diffuse noxious inhibitory control systems?
3. Does sympatho-vagal balance influence temporal summation?
4. Does the hypoalgesic effect to acute increase in blood pressure a result of baroreflex activation?
1. To study the sympatho-vagal balance effect on different limbs of pain perception.
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.
study questions
The study questions are derived from the study objectives:
1. Does sympatho-vagal balance influence pain perception?
2. Does sympatho-vagal balance influence diffuse noxious inhibitory control systems?
3. Does sympatho-vagal balance influence temporal summation?
4. Does the hypoalgesic effect to acute increase in blood pressure a result of baroreflex activation?
Detailed Description:
Hypothesis
We hypothesize that the activation of the sympathetic system, which leads to increased hypertension, rather than the cholinergic response to increased BP, is responsible for antinociceptive effect of hypertension.
2.b objectives
1. To study the sympatho-vagal balance effect on different limbs of pain perception.
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.
2.c study questions
The study questions are derived from the study objectives:
1. Does sympatho-vagal balance influence pain perception?
2. Does sympatho-vagal balance influence diffuse noxious inhibitory control systems?
3. Does sympatho-vagal balance influence temporal summation?
4. Does the hypoalgesic effect to acute increase in blood pressure a result of baroreflex activation?
3\. Subjects and methods
3.a subjects
Every subject will be invited to 2 separate sessions. At least 24 hours will apart the two sessions. The test in each session is described in details in the Hebrew protocol attached to the current protocol in English.
An informed consent will be signed by each subject prior to a thorough interview. The interview, composed of several question regarding prior health problems, current or past use of medications as well as demographic details (as detailed in the Hebrew protocol) will take place in the test room prior to the beginning of the first session.
Screening tests will include detailed interview, blood pressure, heart rate and ECG strip at the beginning of the first(but not the second) session. The first measurement will be taken following 15 minutes complete rest. The second and the third after 5 and 10 minutes, respectively. Blood examinations are not required in this study.
Healthy subjects: 20 age matched subjects (20-50).
We hypothesize that the activation of the sympathetic system, which leads to increased hypertension, rather than the cholinergic response to increased BP, is responsible for antinociceptive effect of hypertension.
2.b objectives
1. To study the sympatho-vagal balance effect on different limbs of pain perception.
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.
2.c study questions
The study questions are derived from the study objectives:
1. Does sympatho-vagal balance influence pain perception?
2. Does sympatho-vagal balance influence diffuse noxious inhibitory control systems?
3. Does sympatho-vagal balance influence temporal summation?
4. Does the hypoalgesic effect to acute increase in blood pressure a result of baroreflex activation?
3\. Subjects and methods
3.a subjects
Every subject will be invited to 2 separate sessions. At least 24 hours will apart the two sessions. The test in each session is described in details in the Hebrew protocol attached to the current protocol in English.
An informed consent will be signed by each subject prior to a thorough interview. The interview, composed of several question regarding prior health problems, current or past use of medications as well as demographic details (as detailed in the Hebrew protocol) will take place in the test room prior to the beginning of the first session.
Screening tests will include detailed interview, blood pressure, heart rate and ECG strip at the beginning of the first(but not the second) session. The first measurement will be taken following 15 minutes complete rest. The second and the third after 5 and 10 minutes, respectively. Blood examinations are not required in this study.
Healthy subjects: 20 age matched subjects (20-50).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: