Ignite Creation Date:
2024-05-06 @ 8:16 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02704793
Status:
COMPLETED
Last Update Posted:
2018-05-22
First Post:
2016-03-05
Brief Title:
Cerebellar rTMS for Essential Tremor
Sponsor:
Mashhad University of Medical Sciences
Organization:
Mashhad University of Medical Sciences
Study Overview
Official Title:
Assessing Clinical Effectiveness of Cerebellar Repetitive Transcranial Magnetic Stimulation rTMS on Severity of Motor Signs of Essential Tremor
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Essential tremor ET is a low-mortality though truly burdensome and debilitating condition which is known to be the second most common movement disorder of the adult population only after restless legs syndrome The prevalence of the disorder in all age groups has been estimated to be 09 Repetitive transcranial magnetic stimulation rTMS is an almost safe technique which has been used in diagnosis and treatment of many neurologic and psychiatric conditions Recent studies have shown that cerebellum has a significant role in development of ET and that rTMS could exert therapeutic effects on its motor symptoms In this study researchers will recruit at least 30 subjects among patients visiting at the Specialty Clinic of Mashhad Medical University according to researchers exclusion and inclusion criteria and after signing a written informed consent will randomly be assigned to either real or sham rTMS On the real rTMS arm patients will be treated with 900 pulses of 1 Hz rTMS on 90 of resting motor threshold RMT delivered over each cerebellar hemisphere for 5 consecutive days and sham treatment will be performed with the same protocol using a small device placed on the TMS coil not visible to the patients producing electrical stimulation less than 3 mili amperes to simulate the sensation of real TMS Subjects ear will be protected with earplugs during both real and sham stimulations After 2 months of follow-up patients will undergo crossover and receive the other treatment as described above Patients would be assessed using Fahn-Tolosa-Marin scale at the baseline and again on days 5 12 and 30 after each real or sham treatment session by a blinded researcher Data will be analysed by another researcher who is also blind
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None