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

Assiut University

Status: Completed

Conditions: Drug Induced Tardive Syndrome (DITS)

Treatments: Procedure: Repetitive transcranial magnetic stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03145311

rTMS in ttt of DITS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 21 to 79 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Real rTMS

Active Comparator group

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

Treatment:

Procedure: Repetitive transcranial magnetic stimulation (rTMS)

Sham rTMS

Sham Comparator group

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.

Treatment:

Procedure: Repetitive transcranial magnetic stimulation (rTMS)