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Trial details
Trial details
Comparison of the impact of two NEurofeedback EEG protocols on the perception and threshold of experimental pain in healthy subjects
Current status:
Approved
|
Date registered:
26/03/2024
Trial version(s)
Current: 29/06/2023
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Main Information
Primary registry identifying number
LBCTR2023065392
Protocol number
CEHDF2110
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
18/06/2023
Primary sponsor
Saint Joseph University of Beirut – Dr Sandra Kobaiter Maarrawi
Primary sponsor: Country of origin
Lebanon
Public title
Comparison of the impact of two NEurofeedback EEG protocols on the perception and threshold of experimental pain in healthy subjects
Acronym
Scientific title
Physiological and validation study in healthy subjects of the effect of two Neurofeedback protocols on acute pain - clinical trial.
Acronym
Brief summary of the study: English
Neuropathic pain is difficult to treat. Studies show that Neurofeedback, a way to voluntarily modulate brain activity, has shown significant results in pain relief. However, the mechanisms and the specificity of the treatment are still not sufficiently investigated. From there, we are interested in passing two protocols of opposite principles (one aimed at the synchronization of the alpha band and the other its desynchronization) aimed at improving the perception and tolerance of pain, in order to understand more meticulously the mechanisms of action of this technique to propose optimal protocols for the management of pain..
Brief summary of the study: Arabic
* من الصعب علاج آلام الأعصاب. تشير الدراسات إلى أن الارتجاع العصبي ، وهي طريقة لتعديل نشاط الدماغ بشكل طوعي ، أظهرت نتائج مهمة في تخفيف الآلام. ومع ذلك ، لا تزال آليات وخصوصية العلاج لم يتم التحقيق فيها بشكل كافٍ. من هناك ، نحن مهتمون بتمرير بروتوكولين لمبادئ متناقضة (أحدهما يهدف إلى مزامنة نطاق ألفا والآخر إلغاء التزامن) يهدف إلى تحسين الإدراك والتسامح مع الألم ، من أجل فهم آليات عمل بدقة أكبر. هذه التقنية لاقتراح البروتوكولات المثلى لإدارة الألم.
Health conditions/problem studied: Specify
neuropathic pain results from damage or disease of the somatosensory nervous system, which affects the central and/or peripheral nervous system . This pain directly interferes with the well-being of sufferers. Indeed, it significantly reduces the quality of life, causes emotional distress and negatively affects the sleep cycle in the affected population, in comparison with the general population and even sufferers of non-neuropathic chronic pain. Consequently, a lack of adaptation to the level of daily life is noted (absences at work, social withdrawal, etc.) . Therefore, appropriate treatment is essential to improve their lives.
Interventions: Specify
1- Neurofeedback + schultz relaxation group : this group will undergo a n autogenic relaxation before the neurofeedback training that aims to increase alpha amplitude over C4. 2- Neurofeedback + Motor imagery training group: this group will undergo a Motor imagery training in which he will visualize his hand moving and then undergo a neurofeedback training to decrease the alpha amplitude over C4. 3 -Two groups Neurofeedback alone: one group will do a neurofeedback training with the target of increasing alpha amplitude and the second group will do a neurofeedback training that will decrease the alpha amplitude. 4- Scham group : this group will not do a neurofeedback training to modify his brainwave instead random values will be displayed during training
Key inclusion and exclusion criteria: Inclusion criteria
- The inclusion criteria are: -Young and healthy subject, aged between 18 and 30 years old -Male and female sex -Right handed - Absence of urticaria reactions to cold -No analgesics 6 hours before visits/tests -Regular sleep cycle (Bergen insomnia scale Ar-Fr) - Perceived stress within the norms(PSS10 Ar-Fr)
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
30
Key inclusion and exclusion criteria: Exclusion criteria
-Chronic Pain -Psychiatric and/or neurological pathologies - Post-traumatic stress disorder (PCL-S) (see appendix 4) -Anxiety or depression (HAD Ar-Fr) (see appendix 5) -Amputations -Uncorrected visual or hearing impairment -History of cardiovascular disorders -History of fainting or seizures -History of frostbite -Open cut of the arm to immerse in the cold pressor test -Fracture of the limb to be immersed -History of Reynaud's phenomenon
Type of Study
Type
Interventional
Type of intervention
Complementary therapies
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
Study phase
N/A
Study design: Purpose
Treatment
Study design: Assignment
Parallel
Pharmaceutical class
N/A
Therapeutic indication
The training suggested, if proved to be beneficial, could be eventually applied in the context of neuropathic pain diseases
Therapeutic benefit
reduce neuropathic pain perception
Biospecimen retention
Samples without DNA
Biospecimen description
Saliva
Target sample size
100
Actual enrollment target size
100
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
15/07/2019
Date of study closure: Type
Anticipated
Date of study closure: Date
01/07/2024
Recruitment status
Recruiting
Date of completion
21/12/2023
IPD sharing statement plan
No
IPD sharing statement description
N/A
Additional data URL
N/A
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Full name of issuing authority Saint Joseph University of Beirut (USJ) – Faculty of Medicine
Secondary identifying number - FM444
Sources of Monetary or Material Support
Name
Saint Joseph University of Beirut (USJ) - Research Council and Faculty of Medicine
Secondary Sponsors
Name
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Sandra
KOBAITER MAARRAWI
Damascus Road PO BOX 11-5076 – Riad el Solh Beirut 11072180.
Lebanon
96171207772
sandra.kobaitermaarrawi@usj.edu.lb
USJ
Scientific
Elio
Ibrahim
Damascus Road PO BOX 11-5076 – Riad el Solh Beirut 11072180.
Lebanon
76598701
elio.ibarhim@net.usj.edu.lb
USJ
Scientific
Lyn
sbeity
Damascus Road PO BOX 11-5076 – Riad el Solh Beirut 11072180.
Lebanon
71856256
lynn.sbeiti@net.usj.edu.lb
USJ
Scientific
Marc
mendelek
Damascus Road PO BOX 11-5076 – Riad el Solh Beirut 11072180.
Lebanon
70744699
marc.mendelek@net.usj.edu.lb
USJ
Scientific
Joseph
Maarawi
Damascus Road PO BOX 11-5076 – Riad el Solh Beirut 11072180.
Lebanon
03742374
joseph.maarrawi1@net.usj.edu.lb
hdf
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Saint Joseph University of Beirut – Faculty of Medicine – Laboratory of Research in Neuroscience
Sandra Kobaiter Maarrawi
neuroscience
Approved
Saint Joseph University of Beirut – Faculty of Medicine – Laboratory of Research in Neuroscience
Joseph Maarrawi
neurosurgery
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
13/12/2022
Pr Michel Scheuer
michel.scheuer@usj.edu.lb
00961 1 421 000 ext 2228
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Chronic pain
2-Propanol (T51.2)
pain
Interventions
Intervention
Description
Keyword
Neurofeedback
a methode of voluntarily brain modulatioin activity for therapeutic purposes
neurofeedback
schultz relaxation
a technique that involves deep breathing and progressive muscle relaxation to induce a state of calm and reduce stress and anxiety.
Schultz Relaxation
Motor imagery
a cognitive practice that involves mentally rehearsing and visualizing specific motor movements to enhance physical performance and improve motor skills.
Motor Imagery
TENS
electrical stimuli on the skin for inducing pain
TENS
Cold Pressor Test
putting the hand in cold water for inducing pain
CPT
Primary Outcomes
Name
Time points
Measure
Reduction of pain perception with TENS after treatment.
before and after each session. And the start and end of experiment.
pain perception using Verbal Rating scale
increase of pain tolerance with CPT after treatment
before and after each session. And the start and end of experiment. Measure 2: maximum time of hand submersion.
maximum time of hand submersion
Key Secondary Outcomes
Name
Time points
Measure
efficacity of schultz relaxation to increase alpha amplitude during training.
before and after each session. And the start and end of experiment
mean alpha wave amplitude using an eeg
efficacity of Motor imagery to decrease alpha amplitude during training
before and after each session. And the start and end of experiment.
mean alpha wave amplitude using an eeg
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial