First rTMS for Treatment of Drug Induced Tardive Syndromes. Double Randomized Clinical Trial
- Conditions
- Drug Induced Tardive Syndrome (DITS)
- Interventions
- Procedure: Repetitive transcranial magnetic stimulation (rTMS)
- Registration Number
- NCT03145311
- Lead Sponsor
- Assiut University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- All patients with the spectrum of Tardive dyskinesia (TD) according to the diagnostic and statistical manual of mental disorders, fourth edition (DSM IV)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham rTMS Repetitive transcranial magnetic stimulation (rTMS) Each patient received repetitive transcranial magnetic stimulation (rTMS) with the same pulse delivery as the 1st group but with the coil placed perpendicular to the scalp. Real rTMS Repetitive transcranial magnetic stimulation (rTMS) Each patient received real repititive transcranial magnetic stimulation (rTMS) 20 HZ at 100% RMT (a total of 2000 pulses to each hand area consisting of 10 trains of 200 pulses with intertrain interval 30 s), over the hand motor area area for 10 consecutive days
- Primary Outcome Measures
Name Time Method Change in AIMS score An average one month Measure the change in AIMS score at the end of the 10th session and then one month later.
- Secondary Outcome Measures
Name Time Method Changes in cortical excitability 10 days Measure the change in cortical excitability before the 1st and then after the 10th session
Trial Locations
- Locations (1)
Eman Khedr
🇪🇬Assiut, Egypt