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To explore the effects of transcranial magnetic stimulation in treatment of post-polio syndrome patients.

To compare the effects of high frequency-rTMS and iTBS in treatment of fatigue in Post-Polio Syndrome based on a randomised-controlled trial using Bereitschaftspotential. - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075838
Enrollment
30
Registered
2024-10-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: G14- Postpolio syndrome

Interventions

Intervention1: High Frequency rTMS: Magnetic stimulation will be provided using Neurosoft MS/MD stimulator with angulated figure of 8 coil to Post-Polio Syndrome patients. Each patient will receive st

Sponsors

All India Institute of Medical Sciences, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria (for Post polio syndrome patients): 1. Participants diagnosed with post-polio syndrome (PPS) as per EFNS (European Federation of Neurological Societies) guideline proposed by Farbu et. al in 2006. It is based on Halsteadâ??s definition from 1991 with emphasis on the new muscle weakness. We preferred this criterion as Pastuszak et. al. and Acler et. al have used the same in their studies. Diagnosis of PPS is clinical and of exclusion. The EFNS criteria includes: o Confirmed history of polio, o Partially or fairly complete neurological and functional recovery after the acute episode, o Period of at least 15 years with neurological and functional stability, o Gradual or abrupt onset of new neurogenic weakness with or without generalised fatigue, muscle atrophy, muscle joint pain, functional loss, cold intolerance. o No other medical explanation found 2. Age: 25-80 years of any gender Inclusion Criteria (for healthy participants) 1. Age matched healthy volunteers

Exclusion criteria

Exclusion criteria: Exclusion criteria (for post-polio Syndrome patients) 1. All other treatable conditions causing muscle fatigue, wasting, generalised fatigue, muscle atrophy, muscle joint pain, functional loss, cold intolerance. 2. Myopathies of any other origin 3. Any other motor neuron disorders 4. Not able to perform hand movements 5. Known hypersensitivity to electrode materials 6. Psychiatric disorders 7. Pregnancy and Lactation 8. History/ family history of seizures 9. Cardiac Pacemaker or any ferromagnetic metallic implants close to target of stimulation area 10. Acute eczema/ bed sore under target of stimulation area 11. Ventilator dependent and tracheostomy patients 12. Not able to understand the language of Informed consent. 13. Not allowing consent for study participation Exclusion Criteria (for healthy participants) 1. Not able to perform hand movements 2. Known hypersensitivity to electrode materials 3. Pregnancy and Lactation 4. History/ family history of seizures 5. Cardiac Pacemaker or any ferromagnetic metallic implants close to target of stimulation area 6. Ventilator dependent and tracheostomy patients 7. Not able to understand the language of Informed consent. 8. Not allowing consent for study participation

Design outcomes

Primary

MeasureTime frame
Bereitschaftspotential (onset) Timepoint: Pre-intervention (baseline) and post-intervention (4 weeks after baseline)

Secondary

MeasureTime frame
Bereitschaftspotential (onset & area under curve), EMG changes, EEG EMG coherence & muscle tissue oxygenation measured by NIRS, & adverse events. Fatigue severity scale(FSS), Patient Health Questionnaire-9 (PHQ-9), Epworth sleepiness scale (ESS), World Health Organization Quality of life BREF(WHOQOL-BREF), & VAS for pain.Timepoint: All assessments will be done pre-treatment (baseline) & post-last treatment. FSS, PHQ-9, ESS, WHOQOL-BREF, VAS for pain & systemic examination will also be followed up after 3 months of last treatment.

Countries

India

Contacts

Public ContactDr. Gita Handa

All India Institute of Medical Sciences, New Delhi

drgita.pmr@aiims.edu9899664489

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026