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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03145311
Enrollment
20
Registered
2017-05-09
Start date
2017-01-15
Completion date
2017-08-30
Last updated
2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Induced Tardive Syndrome (DITS)

Keywords

rTMS, Drug Induced Tardive Syndrome

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.

Interventions

PROCEDURERepetitive transcranial magnetic stimulation (rTMS)

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 79 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in AIMS scoreAn average one monthMeasure the change in AIMS score at the end of the 10th session and then one month later.

Secondary

MeasureTime frameDescription
Changes in cortical excitability10 daysMeasure the change in cortical excitability before the 1st and then after the 10th session

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026