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To compare the safety and effectiveness of repetitive transcranial magnetic stimulation and botulinum toxin type A treatments in patients of dystonia

Comparison of efficacy and safety of repetitive transcranial magnetic stimulation versus botulinum toxin type A in idiopathic dystonia: A crossover randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/112913
Enrollment
60
Registered
2026-06-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: G245- Blepharospasm Health Condition 2: G249- Dystonia, unspecified Health Condition 3: G242- Idiopathic nonfamilial dystonia Health Condition 4: G244- Idiopathic orofacial dystonia Health Condition 5: G248- Other dystonia Health Condition 6: G243- Spasmodic torticollis

Interventions

Intervention1: Repetitive transcranial magnetic stimulation: Dose, frequency route of administration: Repetitive TMS will be given to the patients by using Magstim Rapid- 2 (Whiteland, Walsh, UK) with

Sponsors

Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: As dystonia is a clinical diagnosis and there are no clinically available laboratory tests or imaging techniques, nor are there validated diagnostic criteria that can be applied, patients with a clinical diagnosis of focal dystonia in the form of benign essential blepharospasms, craniofacial dystonia, cervical dystonia, laryngeal dystonia, lingual dystonia, writer s cramp, musician dystonia, focal hand dystonia, leg dystonia will be included in the trial. Patients of the age group of more than 18 years will be included. Patients who have given a written informed consent to participate in the study will be included.

Exclusion criteria

Exclusion criteria: Patients with a history of head trauma, peripheral trauma, encephalitis, meningitis, toxin exposure, drug exposure, perinatal anoxia will be excluded. Patients with a presence of neurological abnormality like seizures, dementia, ataxia, weakness, spasticity, amyotrophy, clinical evaluation suggesting a psychogenic cause, abnormal brain imaging, abnormal laboratory findings will be excluded. Pregnant patients and lactating mothers will be excluded.

Design outcomes

Primary

MeasureTime frame
1.Improvement in UDRS, BFMDRS, JRS, physician rating scale, patient rating scale, Modified TWSTRS, WCRS, handwriting will be recorded after 1 month, 2 months and 3 months following botulinum toxin A injection. 2. Improvement in UDRS, BFMDRS, JRS, physician rating scale, patient rating scale, Modified TWSTRS, WCRS, handwriting will be recorded after 1 month, 2 months and 3 months following rTMS sessions. 3.Comparision of the improvement, if any, following botulinum toxin A and rTMS in UDRS, BFMDRS, JRS, physician rating scale, patient rating scale, Modified TWSTRS, WCRS, handwriting will be recorded after 1 month, 2 months and 3 months. Timepoint: 1 month, 2 months and 3 months.

Secondary

MeasureTime frame
1. Adverse effects following rTMS and /or BoNT if any, in patients of dystonia will be assessed at 1 month, 2 month and 3 months.Timepoint: 1 month, 2 month and 3 months.

Countries

India

Contacts

Public ContactRuchika Tandon

Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow

rtlib161080@gmail.com9935361906

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026