Investigating the effect of galvanic vestibular stimulation and vestibular rehabilitation on spatial memory of patients with amnestic mild cognitive impairment
Investigating the effect of galvanic vestibular stimulation (GVS) and vestibular rehabilitation (VR) on spatial memory of patients with amnestic mild cognitive impairment (aMCI)
Design
Randomized, controlled clinical trial with a parallel group design on 48 patients. Randomization was carried out with Random Allocation Software.
Settings and conduct
Patients with amnestic mild cognitive impairment, referred to School of Rehabilitation, affiliated to Tehran University of Medical Sciences, undergo Mini-Mental State Examination, Montreal Cognitive Assessment, Rey's auditory-verbal, CANTAB visual-spatial memory, video head impulse and force-plate tests before randomization. Immediately after the end of the intervention period and one month later, the tests will be repeated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosed with amnestic mild cognitive impairment; MMSE test score <21; Montreal cognitive assessment score 19 and 24.
Non-inclusion criteria: Color blindness; neck pain or limitation in neck range of motion; anticholinergic drug consumption; alcoholism or addiction; orthopedic problems in the past 6 months; obvious lower extremity deformities; rheumatic and/or metabolic diseases
Intervention groups
Intervention group 1: Receiving galvanic vestibular stimulation (three 20-minute sessions; once a week) and vestibular rehabilitation (physical exercises; twice a day for 1 month)
Intervention group 2: Receiving galvanic vestibular stimulation (three 20-minute sessions; once a week).
Intervention group 3: Receiving vestibular rehabilitation (physical exercises; twice a day for 1 month).
Control group: Receiving no intervention.
Main outcome variables
Montreal Cognitive Assessment, learning, and recall scores; percentage and latency of CANTAB correct answers; memory span; vestibulo-ocular reflex gain; displacement and velocity of displacement of center of pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160131026279N3
Registration date:2020-05-05, 1399/02/16
Registration timing:prospective
Last update:2020-05-05, 1399/02/16
Update count:0
Registration date
2020-05-05, 1399/02/16
Registrant information
Name
Mansoureh Adel Ghahraman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 4364
Email address
madel@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of galvanic vestibular stimulation and vestibular rehabilitation on spatial memory of patients with amnestic mild cognitive impairment
Public title
Effect of rehabilitation on treatment of mild cognitive impairment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed with aMCI
MMSE test score <21 for participants with primary school education and <23 for participants with a university degree
MoCA test score between 19 and 24
Adequate visuomotor coordination based on the standard score (Z Score ± 1) in motor screening task (MOT) test
Normal or modified visual acuity or with glasses (20/20) using the Snellen chart in order to correctly diagnose CANTAB test forms
Normal hearing ability or corrected hearing loss with hearing aid to hear the stimulus in the force plate test
Exclusion criteria:
Color blindness according to Ishihara test for color blindness
Neck pain or limitation in neck range of motion
Anticholinergic drug consumption (e.g. hyoscine and atropine) consumption
Consumption of drugs affecting vestibulo-ocular reflex such as Cinnarizine , betahistine, painkillers, and tranquilizers from 48 hours prior to tests
History of orthopedic problems in the last 6 months (lower extremity fractures, dislocation, and pain)
Obvious lower extremity deformities such as scoliosis and kyphosis according to observation of a physiotherapist
History of rheumatic and/or metabolic diseases
History of alcoholism or addiction
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Individual random assignment to four equal groups with block randomization method using blocks of size 4; Randomization and random sequential allocation: done with Random Allocation Software; Allocation concealment: done with sequentially numbered, sealed, opaque envelopes
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of School of Nursing and Midwifery & Rehabilitation ,Tehran University of Medical S
Street address
Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1148956111
Approval date
2020-02-19, 1398/11/30
Ethics committee reference number
IR.TUMS.FNM.REC.1398.229
Health conditions studied
1
Description of health condition studied
amnestic mild cognitive impairment
ICD-10 code
G31.84
ICD-10 code description
Mild cognitive impairment, so stated
Primary outcomes
1
Description
Montreal Cognitive Assessment score
Timepoint
Before, immediately after the end of the intervention period, and one month later
Method of measurement
Montreal Cognitive Assessment (MoCA)
2
Description
learning score
Timepoint
Before, immediately after the end of the intervention period, and one month later
Method of measurement
Rey Auditory Verbal Learning Test
3
Description
immediate recall score
Timepoint
Before, immediately after the end of the intervention period, and one month later
Method of measurement
Rey Auditory Verbal Learning Test
4
Description
Delayed recall score
Timepoint
Before, immediately after the end of the intervention period, and one month later
Method of measurement
Rey Auditory Verbal Learning Test
5
Description
Percentage of correct answers in pattern recognition memory (PRM)
Timepoint
Before, immediately after the end of the intervention period, and one month later
Method of measurement
CANTAB test
6
Description
Response latency in Delayed Matching to Sample
Timepoint
Before, immediately after the end of the intervention period, and one month later
Method of measurement
CANTAB test
7
Description
percentage of correct selection in Delayed Matching to Sample
Timepoint
Before, immediately after the end of the intervention period, and one month later
Method of measurement
CANTAB test
8
Description
percentage of errors in Paired Associates Learning
Timepoint
Before, immediately after the end of the intervention period, and one month later
Method of measurement
CANTAB test
9
Description
Spatial Span length
Timepoint
Before, immediately after the end of the intervention period, and one month later
Method of measurement
CANTAB test
10
Description
vestibulo-ocular reflex gain
Timepoint
Before, immediately after the end of the intervention period, and one month later
Method of measurement
video head impulse test (vHIT)
11
Description
percentage of overt saccades
Timepoint
Before, immediately after the end of the intervention period, and one month later
Method of measurement
video head impulse test (vHIT)
12
Description
percentage of covert saccades
Timepoint
Before, immediately after the end of the intervention period, and one month later
Method of measurement
video head impulse test (vHIT)
13
Description
Vestibulo-ocular reflex gain asymmetry
Timepoint
Before, immediately after the end of the intervention period, and one month later
Method of measurement
video head impulse test (vHIT)
14
Description
displacement of center of pressure in both anterior-posterior and medial-lateral directions in anticipation, weight transfer, and locomotion
Timepoint
Before, immediately after the end of the intervention period, and one month later
Method of measurement
force-plate test
15
Description
velocity of displacement of center of pressure in both anterior-posterior and medial-lateral directions in anticipation, weight transfer, and locomotion
Timepoint
Before, immediately after the end of the intervention period, and one month later
Method of measurement
force-plate test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: receiving GVS and VR, GVS: Subliminal noisy GVS, 20 min, once a week, three sessions. VR: Cooksey-Cawthorne rehabilitation exercises, 30 min, twice a day for one month
Category
Rehabilitation
2
Description
Intervention group 2: receiving VR only. VR: Cooksey-Cawthorne rehabilitation exercises, 30 min, twice a day for one month
Category
Rehabilitation
3
Description
Intervention group 3: receiving GVS only. GVS: Subliminal noisy GVS, 20 min, once a week, three sessions.
Category
Rehabilitation
4
Description
Control group: no intervention
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Audiology clinic, School of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
Mansoureh Adel Ghahraman
Street address
Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 0636
Email
madel@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shabnam Noroozzadeh
Street address
Tehran University of Medical Sciences (TUMS), Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3627
Email
research@tums.ac.ir
Grant name
Annual funding, School of Rehabilitation
Grant code / Reference number
98-3-103-45574
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansoureh Adel Ghahraman
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 4364
Email
madel@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansoureh Adel Ghahraman
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 4364
Fax
+98 21 7753 4133
Email
madel@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansoureh Adel Ghahraman
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 4364
Fax
+98 21 7753 4133
Email
madel@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
-
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Reporting as a PhD dissertation and papers
When the data will become available and for how long
2022 and after
To whom data/document is available
All people
Under which criteria data/document could be used
In accordance with Tehran University of Medical Sciences copyright
From where data/document is obtainable
Databases for papers and the library of the School of Rehabilitation, TUMS, for dissertation
What processes are involved for a request to access data/document
For papers depends on the journal's policy. For the dissertation, studying in the library