First rTMS for Treatment of Drug Induced Tardive Syndromes. Double Randomized Clinical Trial

Drug Induced Tardive Syndrome (DITS) Clinical Trial

Official title:

First Repetitive Transcranial Magnetic Stimulation for Treatment of Drug Induced Tardive Syndromes. Double Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03145311
• Other study ID #: rTMS in ttt of DITS
• Status: Completed
• Phase: N/A
• Start date: January 15, 2017
• Est. completion date: August 30, 2017

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Induced Tardive Syndrome (DITS)
• Syndrome

Intervention

Procedure:
• Repetitive transcranial magnetic stimulation (rTMS)

Locations

Country	Name	City	State
Egypt	Eman Khedr	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in AIMS score	Measure the change in AIMS score at the end of the 10th session and then one month later.	An average one month
Secondary	Changes in cortical excitability	Measure the change in cortical excitability before the 1st and then after the 10th session	10 days