search
Back to results

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

Primary Purpose

Drug Induced Tardive Syndrome (DITS)

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation (rTMS)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Induced Tardive Syndrome (DITS) focused on measuring rTMS, Drug Induced Tardive Syndrome

Eligibility Criteria

21 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eman Khedr

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Real rTMS

Sham rTMS

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in AIMS score
Measure the change in AIMS score at the end of the 10th session and then one month later.

Secondary Outcome Measures

Changes in cortical excitability
Measure the change in cortical excitability before the 1st and then after the 10th session

Full Information

First Posted
April 28, 2017
Last Updated
September 12, 2020
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT03145311
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2017 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
August 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Induced Tardive Syndrome (DITS)
Keywords
rTMS, Drug Induced Tardive Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real rTMS
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Repetitive transcranial magnetic stimulation (rTMS)
Primary Outcome Measure Information:
Title
Change in AIMS score
Description
Measure the change in AIMS score at the end of the 10th session and then one month later.
Time Frame
An average one month
Secondary Outcome Measure Information:
Title
Changes in cortical excitability
Description
Measure the change in cortical excitability before the 1st and then after the 10th session
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman M Khedr, MD
Organizational Affiliation
Professor of Neurology, Faculty of Medicine, Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eman Khedr
City
Assiut
ZIP/Postal Code
11517
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30317532
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs