Theta-burst stimulation as an adjuvant to treatment of upper limb spasticity in stroke: a pilot study

Not Applicable

• Conditions: pper limb spasticity in stroke survivors; Upper limb spasticity in stroke survivors; Stroke - Ischaemic

• Registration Number: ACTRN12613000641796
• Lead Sponsor: Flinders University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

History of stroke at least 12 months before the recruitment into the study
Spasticity of moderate severity (Modified Ashworth Score = 3) in at least one upper limb
No contraindications to TMS or TBS
No other neurological or musculoskeletal disorders affecting the cervical spine.
Concurrent treatment with botulinum toxin

Exclusion Criteria

Patients with cognitive deficits and patients unable to reliably follow instructions
Patients with unstable cardiac dysrhythmias, pacemakers etc
Patients with history of seizure(s) or family history of seizures in first degree relatives
Patients who have undergone brain surgery or had brain trauma
Patients with history of intracranial hypertension
Patients using tranquilizers or medications that can alter the seizure threshold unless they are able to cease the medications at least two weeks period to the stimulation
Patients with intracranial metallic, magnetic pieces, with pacemakers or any other device
Any other coexisting neurological or musculoskeletal condition that can result in contracture, spasticity or hypertonia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tardieu Scale immediately post-intervention [Immediately post-intervention period];Box and Block Test immediately post-intervention [Immediately post-intervention period]

Secondary Outcome Measures

Name	Time	Method
Tardieu Scale at 2 weeks post-intervention [2 weeks post-intervention period];Box and Block Test at 2 weeks post-intervention [2 weeks post-intervention period];EuroQol Quality of Life Scale[Immediately post-intervention period<br>2 weeks post-intervention period];Stroke Impact Scale[Immediately post-intervention period <br>2 weeks post-intervention period];TMS measurements: amplitude of motor evoked potential (MEP) from the target muscle, ipsilateral silent period (ISP), recruitment curve.[Immediately post-intervention period <br>2 weeks post-intervention period]