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

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

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.

Study Overview

• Status: Completed
• Conditions: Drug Induced Tardive Syndrome (DITS)
• Intervention / Treatment: Procedure: Repetitive transcranial magnetic stimulation (rTMS)

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 11517
    • Eman Khedr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Real 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	Procedure: Repetitive transcranial magnetic stimulation (rTMS)
Sham Comparator: Sham 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.	Procedure: Repetitive transcranial magnetic stimulation (rTMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cortical excitability	Measure the change in cortical excitability before the 1st and then after the 10th session	10 days

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Eman M Khedr, MD, Professor of Neurology, Faculty of Medicine, Assiut University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2017
• Primary Completion (Actual): August 30, 2017
• Study Completion (Actual): August 30, 2017

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 12, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: rTMS, Drug Induced Tardive Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: rTMS in ttt of DITS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No