Cancer treatment-related cognitive disorders, including memory deficits in the short term, affect a person's normal functioning and even lead to impaired activities of daily living of the people. In recent years, research into the impact on cognitive function and memory in these patients, but a closer look at the effectiveness they need to do more studies are listed. Neurofeedback therapy is one of the recommended interventions to improve memory after breast cancer treatment,But given that still in this area, especially in our country, studies have been done and also according to the needs of patients for intervention in this field, this study took shape. the purpose of this investigation,The effects of neurofeedback on short-term memory and quality of life of women who are admitted to Shohada Hospital which Been treated for breast cancer and your treatment period has elapseda and impaired short-term memory have been caused by the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071728964N1
Registration date:2016-10-11, 1395/07/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-11, 1395/07/20
Registrant information
Name
Pooria Sarvghadi
Name of organization / entity
Faculty of Rehabilitation, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3502 3238
Email address
sarvghadi.pooria@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2016-12-05, 1395/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of neurofeedback on short-term memory and quality of life after breast cancer treatment
Public title
The effect of neurofeedback on short-term memory and quality of life after breast cancer treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. Patients agreed to participate in research'; 2. One-way adult patients after breast cancer surgery and only a surgical treatment, chemotherapy and radiation therapy is given; 3. Impaired short-term memory is demonstrated by Wechsler test; 4. no history of brain tumor patients or history of psychiatric disorders such as depression, obsession and neurological diseases including Alzheimer's, Parkinson's and stroke.
Exclusion criteria: 1. Neurofeedback therapy treated patients during surgery, chemotherapy and radiation; 2. In case of relapse and metastasis (grade 4 breast cancer); 3. Patients for whatever reason do not wish to continue treatment, emigrated or died; 4. Not been previously treated patients with short-term memory.
Age
From 16 years old to 74 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Velenjak, University Boulevard
City
Tehran
Postal code
Approval date
2016-05-29, 1395/03/09
Ethics committee reference number
IR.SBMU.REC.1395.22
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50.9
ICD-10 code description
Breast cancer
Primary outcomes
1
Description
Quality of Life
Timepoint
Before and after the intervention
Method of measurement
SF-36 questionnaire
2
Description
Short Term Memory
Timepoint
Before and after the intervention
Method of measurement
Wechsler memory scale
Secondary outcomes
1
Description
Alpha peak
Timepoint
Before, after 10 sessions and at the end of intervention
Method of measurement
Neurofeedback device
Intervention groups
1
Description
Intervention group:
After taking a detailed history and complete a questionnaire on background information (demographic), and measurement scales before intervention Including tests of verbal memory test carried out in Wechsler memory scale and quality of life questionnaire SF-36,Neurofeedback treatment in the intervention group and the control group for placebo (Placebo) was performed.
In this study, the purpose of neurofeedback, using neurofeedback flexicomp Infiniti eight-channel devices and the computer. After insertion of the electrode and wires, first, a raw EEG recorded 9 points CZ (in both open and closed eyes, quiet reading, listening, painting), FZ, PZ, F3, F4, will be carried out and after 10 sessions of arousal on it and re-interpret the raw EEG, 10 second session on alpha peak enhancement work will be in Fz point. Neurofeedback devices and computer room where it was located in a quiet environment, with minimal visual and auditory stimuli to keep up with minimal artifacts.
Category
Rehabilitation
2
Description
Control group:
In the control group, while the electrodes were placed on their heads sat in front of the monitor, but the speakers was interrupted.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Occupational Therapy, Shohada Tajrish Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice-Chancellor (Research and Technology) shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Shahid Chamran Highway Street Yemen - Arab street next shahid Ayatollah Taleghani Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice-Chancellor (Research and Technology) shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ebn Sina hospital
Full name of responsible person
Pooria Sarvghadi
Position
Occupational Therapist
Other areas of specialty/work
Street address
St. Hurr Ameli, next to the barn Astan Quds
City
Mashhad
Postal code
Phone
+98 51 3502 3238
Fax
Email
sarvghadi.pooria@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ebn SIna hospital
Full name of responsible person
Pooria Sarvghadi
Position
Occupational Therapist/ Master of science
Other areas of specialty/work
Street address
St. Hurr Ameli, next to the barn Astan Quds
City
Mashhad
Postal code
Phone
+98 51 3502 3238
Fax
Email
sarvghadi.pooria@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Rehabilitatin, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pooria Sarvghadi
Position
Master of science/Occupational Therapy
Other areas of specialty/work
Street address
Faculty of Rehabilitatin, Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 3502 3238
Fax
Email
sarvghadi.pooria@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)