UMIN-CTR Clinical Trial

Basic information
Public title	Effect of neurofeedback therapeutic interventions on EEG central nervous, PTSD and muscle fatigue parameters in military seniors with post-traumatic stress disorder.
Acronym	Effect of neurofeedback therapeutic interventions on EEG central nervous, PTSD and muscle fatigue parameters in military seniors with post-traumatic stress disorder.
Scientific Title	Effect of an integrated mind-body neurotherapy on chronic stress and neuromuscular fatigue in patients with PTSD. A randomized control study.
Scientific Title:Acronym	Effect of an integrated mind-body neurotherapy on chronic stress and neuromuscular fatigue in patients with PTSD. A randomized control study.
Region	Asia(except Japan)

Condition
Condition	male adults with PTSD
Classification by specialty	Medicine in general Neurology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect of an integrated mind-body neurotherapy on chronic stress and neuromuscular fatigue in patients with PTSD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical neurophysiology and PTSD checklist
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	30 three time-weekly sessions of alpha-theta neurofeedback training (NF) protocol combined with imagined muscle contraction training
Interventions/Control_2	No intervention for three months
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	45 years-old <=
Age-upper limit	60 years-old >=
Gender	Male
Key inclusion criteria	(1) having normal vision, hearing and dexterity, lack of personal background of any other mental and neurological disorders; (2) lack of substance abuse and main medical problems; (3) military men between 45 and 60 years of age; (4) written agreement with the research processes; (5) having minimum elementary education; (6) having physical and cognitive ability confirmed through documentation on their medical records, and (7) interest in participating in the intervention program.
Key exclusion criteria	Any participant not complying with the inclusion criteria is excluded from the research process.
Target sample size	22

Research contact person
Name of lead principal investigator	1st name Mostafa Middle name Last name Sarabzadeh
Organization	National Elites Foundation, Tehran, Iran
Division name	Exercise Physiology and NeuroPhysiotherapy
Zip code	09821
Address	No. 209, between Navab and Roudaki St., Azadi street, Tehran
TEL	0989376293463
Email	m.sarabzadeh89@mailfa.com

Public contact
Name of contact person	1st name Mostafa Middle name Last name Sarabzadeh
Organization	National Elites Foundation, Tehran, Iran
Division name	Exercise Physiology and NeuroPhysiotherapy
Zip code	09821
Address	No. 209, between Navab and Roudaki St., Azadi street, Tehran
TEL	0989376293463
Homepage URL
Email	m.sarabzadeh89@mailfa.com

Sponsor
Institute	National Elites Foundation, Tehran, Iran - Department of Physiotherapy, AJA University of Medical Sciences, Tehran
Institute
Department

Funding Source
Organization	Department of Physiotherapy, AJA University of Medical Sciences, Tehran
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Department of Physiotherapy, AJA University of Medical Sciences, Tehran
Address	Aja University of medical science, Kargar shomali, Sakhaei st
Tel	09821-86096350-5
Email	m.soleimanifar@ajaums.ac.ir

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	22
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 03 Month 01 Day
Date of IRB	2019 Year 01 Month 27 Day
Anticipated trial start date	2019 Year 04 Month 10 Day
Last follow-up date	2021 Year 06 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 09 Month 03 Day
Last modified on	2021 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051804