Comparison of the effectiveness of cognitive rehabilitation of stroke patients with spatial neglect using the Prism Adaption and combined Prism Adaption and the Trans-cranial Magnetic Stimulation: a randomized control clinical trial
This study aimed to investigate the effect of cognitive rehabilitation using the prism combined the trans cranial magnetic stimulation among stroke patients with spatial neglect
Design
This study will be a single blind, sham controlled randomize clinical trial in phase 2 with parallel group design. There will be 18 patient with stroke related neglect that will enroll between Augusta 2017 and September 2018.
Settings and conduct
The Intervention group: The stroke patients with neglect underwent Continuous theta-burst Trans cranial Magnetic Stimulation combined with Prism Adaptation to mirror therapy for 10 sessions.
The control group: The stroke patients with neglect underwent sham Trans cranial Magnetic Stimulation combined with prism adaptation to mirror therapy for 10 sessions.
Neglect and stroke-related functional assessment tests will be administered before and after 10 sessions of therapy for assessment of therapy efficacy. The present study will be conducted at Shariati Hospital and the National Center for Mapping of the Brain:;
Participants/Inclusion and exclusion criteria
Inclusion criteria: Neglect due to stroke; being right handed.
Non inclusion criteria: age less than 18 and more than 80 years; severe head trauma in the last 3 months; severe chronic health conditions such as advanced cancer; dementia; heart pacemaker.
Intervention groups
The intervention group will receive Continuous theta-burst Trans cranial Magnetic Stimulation combined with Prism Adaptation to mirror therapy for 10 sessions. The stroke patients in the sham group will receive sham Trans cranial Magnetic Stimulation combined with prism adaptation to mirror therapy for 10 sessions.
Main outcome variables
Unilateral neglect
General information
Reason for update
Acronym
cognitive rehabilitation Trans-cranial Magnetic Stimulation (TMS) Prism Adaption (PA)
IRCT registration information
IRCT registration number:IRCT20170423033606N3
Registration date:2018-11-25, 1397/09/04
Registration timing:retrospective
Last update:2018-11-25, 1397/09/04
Update count:0
Registration date
2018-11-25, 1397/09/04
Registrant information
Name
SHole Vatanparasti
Name of organization / entity
ICSS
Country
Iran (Islamic Republic of)
Phone
+98 433839881
Email address
sholevatanparast100@gmail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-07-22, 1396/04/31
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of cognitive rehabilitation of stroke patients with spatial neglect using the Prism Adaption and combined Prism Adaption and the Trans-cranial Magnetic Stimulation: a randomized control clinical trial
Public title
The effect of Prism Adaption and the Trans-cranial Magnetic Stimulation in spatial neglect treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The right-handed patients
stroke in right hemisphere with unilateral neglect
Exclusion criteria:
Minimum age 18 and Maximum age 80 years
intense pain
cerebral edema
brain trauma
pacemaker of heart
National Institutes of Health Stroke scale
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to one of two groups with the help of random numbers table.
Blinding (investigator's opinion)
Single blinded
Blinding description
After randomization, intervention group patients will receive trans cranial magnetic stimulation (TMS) with the following protocol: 801 pulses will be delivered in 267 bursts and each burst consisted of 3 pulses at 30 Hz. Each session of stimulation will last 45 seconds as stimulation bursts will be delivered at 6 Hz. Magnetic coil will be tangentially placed at P3, with the handle pointing posterior. Sham group patients will receive the same stimulation protocol and the magnetic coil will be placed at P3. The only difference will be holding the magnetic coil vertical to the scalp that will resulted in no brain stimulation during the stimulation period. However, patients will hear magnetic pulses' sounds (clicks) without receiving any stimulation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Between Sheikh Fazlollah Noori and Shahid Chamran highway, Shahid Hemmat high way
City
Tehran
Province
Tehran
Postal code
57168-47146
Approval date
2017-05-13, 1396/02/23
Ethics committee reference number
IR.IUMS.REC.1396.93012334
Health conditions studied
1
Description of health condition studied
Stroke with unilateral spatial neglect
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as hemorrhage or infarction
Primary outcomes
1
Description
Unilateral neglect
Timepoint
Before and after 10 session treatment
Method of measurement
Line Bisection Test; Star Cancellation Test; The Catherine Bergego Scale
Secondary outcomes
1
Description
Neurological function
Timepoint
Before and after 10 session treatment
Method of measurement
The Modified Rankin Scale and The Barthel Index Scale
Wechsler Memory Scale: Sub Test, River Mill Scale: Sub Test, Rey Auditory Verbal Learning Test
8
Description
Spatial ability unilateral neglect
Timepoint
Before and after 10 session treatment
Method of measurement
Mental Rotation Test,Visualizing Test and Water Level Test
Intervention groups
1
Description
Intervention group: In each session, patients will receive trans cranial magnetic stimulation (TMS). Inhibitory TMS will be as following protocol: 801 pulses will be delivered in 267 bursts and each burst will consist of 3 pulses at 30 Hz. Each session of stimulation will last 45 seconds as stimulation bursts will deliver at 6 Hz. Magnetic coil will place tangentially at P3 and the coil handle will be placed in posterior. After stimulation, patients will receive mirror therapy for 20 minutes while will wear prism glasses. Prism adaption glasses will deviate the visual fields 10 degrees to the right. In each 20 minutes of mirror therapy, patients will sit at a table containing a vertical mirror with the size of 35*35*30 cm. Patients will be asked to put their pare tic hands inside the mirror box and their intact hand in front, so mirror image of the intact hand will seem as the pare tic hand in the patients' eyes. Then, patients will open and close their hands and fingers while will look at their hands' images in the mirror. Also, they will try to do the same movements with their pare tic hands meanwhile. This therapy will continue for 10 daily sessions in 2 weeks.
Category
Rehabilitation
2
Description
Sham stimulation control group: In each session, patients will receive trans cranial magnetic stimulation (TMS). Inhibitory TMS will be as following protocol: 801 pulses will deliver in 267 bursts and each burst will consist of 3 pulses at 30 Hz. Each session of stimulation will last 45 seconds as stimulation bursts will deliver at 6 Hz. Magnetic coil will couple vertically place at P3, with the handle will be placed at posterior. After stimulation, patients will receive mirror therapy for 20 minutes while will wear prism glasses. Prism adaption glasses will deviate the visual fields 10 degrees to the right. In each 20 minutes of mirror therapy, patients will sit at a table contain a vertical mirror in size of 35*35*30 cm. Patients will ask to put their pare tic hands inside the mirror box and their intact hand in front, so mirror image of the intact hand will seem as the pare tic hand to the patients' eyes. Then, patients will open and close their hands and fingers while will look at their hands' images in the mirror. Also, they will try to do the same movements with their pare tic hands meanwhile. This therapy will be done during 10 daily sessions for 2 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospitalal
Full name of responsible person
ُShahram Ovis Garan
Street address
Next to University Tarbiyat Modares.,Kargar Jonobi Street.