Effect of electroconvulsive therapy on motor and psychiatric symptoms of Parkinson's patients who resistant to drug treatment
Design
Open-label, single arm, clinical trial.
Settings and conduct
This study, which will be conducted at Farabi hospital in Kermanshah city, is not blinded one.Patients, along with ECT, will be treated with dopaminergic drugs.Patients at the beginning of the study, the end of the sixth week and follow up (one month after the end of the study) will be evaluated in terms of motor and psychiatric symptoms.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Parkinson's patients with motor and psychiatric symptoms resistant to drug therapy; Age between 40 and 75 years
Exclusion criteria:Cardiovascular patients; Patients with cognitive impairment;
Patients with the history of seizure, stroke
Intervention groups
The intervention group in addition to dopaminergic medications, will receive a 25-julestwo-sided frontotemporal ectoplasmic twice a week.If the person does not get seizure, the next stimulus is performed at 50, 75, 100 jules.During this stage of anesthesia we can induce seizures up to 4 times
Main outcome variables
Motor symptoms; psychiatric symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N95
Registration date:2018-06-15, 1397/03/25
Registration timing:registered_while_recruiting
Last update:2018-06-15, 1397/03/25
Update count:0
Registration date
2018-06-15, 1397/03/25
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-19, 1395/03/30
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of electroconvulsive therapy on motor and psychiatric symptoms of drug-resistant Parkinson's patients
Public title
Electroconvulsive therapy and Parkinson
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Parkinson's patients with motor and psychiatric symptoms resistant to drug therapy
Age between 40 and 75 years
Exclusion criteria:
Cardiovascular patients; Patients with cognitive impairment; Patients with the history of seizure, stroke
Age
From 40 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-02-28, 1396/12/09
Ethics committee reference number
ir.kums.rec.1396.44
Health conditions studied
1
Description of health condition studied
Parkinson
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Motor symptoms
Timepoint
At the beginning of the study, the end of the sixth week and one month after the end of the study
Method of measurement
Using the Unified Parkinson's disease rating scale (UPDRS)
2
Description
Psychiatric symptoms
Timepoint
At the beginning of the study, the end of the sixth week and one month after the end of the study
Method of measurement
Using the Brief Psychiatric Rating Scale (BPRS)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group in addition to dopaminergic medications, will receive a 25-julestwo-sided frontotemporal ectoplasmic twice a week.If the person does not get seizure, the next stimulus is performed at 50, 75, 100 jules.During this stage of anesthesia we can induce seizures up to 4 times