Clinical trial NCT03145311: First rTMS for Treatment of Drug Induced Tardive Syndromes. Double Randomized Clinical Trial
Official title: First Repetitive Transcranial Magnetic Stimulation for Treatment of Drug Induced Tardive Syndromes. Double Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Induced Tardive Syndrome (DITS)
Keywords: rTMS, Drug Induced Tardive Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of rTMS on DITS. Twenty patients with DITS were recruited from the outpatient clinic of Aswan University Hospital. The patients were classified into two equal groups, 1st group received real high frequency rTMS at 100% RMT and the 2nd group received sham stimulation with the same pulse delivery but with the coil placed perpendicular to the scalp. For each patient 10 sessions were administered once per day for 5 consecutive days each week for two weeks. All patients were assessed before rTMS and immediately after the end of the 10 sessions. This study is double blinded (the doctor and the patients). Assessment with AIMS scale and different parameters of cortical excitability were performed before and after the end of sessions treatment.

Detailed description: The aim of this study was to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS) on drug induced tardive syndromes.

the effect of rTMS compare. Twenty patients with drug induced tardive syndromes were recruited from the outpatient clinic of Aswan University Hospital. The patients were classified into two equal groups, 1st group received real 20 Hz-rTMS at 100% RMT (a total of 2000 pulses to each hand area consisting of 10 trains of 200 pulses with intertrain interval 30 s), and the 2nd group received sham stimulation with the same pulse delivery as the 1st group but with the coil placed perpendicular to the scalp. For each patient 10 sessions were administered once per day for 5 consecutive days each week for two weeks. All patients were assessed before rTMS and immediately after the end of the 10 sessions. The patients did not know which type of stimulation they received and to ensure that, the study was double blinded the doctor who assessed the patients didn't know which type of stimulation the patients received. None of the patients had had rTMS before and were unaware of the type of stimulation.The AIMS scale and different parameters of cortical excitability were assessed before and after the end of session treatment.

Eligibility criteria: Inclusion Criteria:

* All patients with the spectrum of Tardive dyskinesia (TD) according to the diagnostic and statistical manual of mental disorders, fourth edition (DSM IV)

Exclusion Criteria:

* None of the patients suffered from any other clinically relevant disorders.
* We exclude any patient with pacemaker or metallic devices
* patients with history of epilepsy or metabolic diseases.

Primary outcomes:
measure: Change in AIMS score
timeFrame: An average one month
Secondary outcomes:
measure: Changes in cortical excitability
timeFrame: 10 days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Eman Khedr
Study officials:
affiliation: Professor of Neurology, Faculty of Medicine, Assiut University
name: Eman M Khedr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khedr EM, Al Fawal B, Abdelwarith A, Saber M, Rothwell JC. Repetitive transcranial magnetic stimulation for treatment of tardive syndromes: double randomized clinical trial. J Neural Transm (Vienna). 2019 Feb;126(2):183-191. doi: 10.1007/s00702-018-1941-x. Epub 2018 Oct 13.