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

NCT03145311 | Completed

• 1 other identifier: rTMS in ttt of DITS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Induced Tardive Syndrome (DITS)

Keywords

rTMS, Drug Induced Tardive Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in cortical excitability

  10 days

Study Arms (2)

Real rTMS

ACTIVE COMPARATOR

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 rTMS

SHAM COMPARATOR

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)

Interventions

Repetitive transcranial magnetic stimulation (rTMS) PROCEDURE

Real rTMS; Sham rTMS

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Eman Khedr

Asyut, 11517, Egypt

Location

Related Publications (1)

• 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.

  PMID: 30317532 DERIVED

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Eman M Khedr, MD

  Professor of Neurology, Faculty of Medicine, Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 9, 2017
• Study Start: January 15, 2017
• Primary Completion: August 30, 2017
• Study Completion: August 30, 2017
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)