NCT02526238

Brief Summary

This is a double blinded, randomized control trial with a pretest-posttest control and interventional group design. The assessor is blinded to all assessments and evaluations. All patients with subacute stroke undergo in-patient or out-patient rehabilitation are screened initially by a series of screening test. Suitable patients are assigned randomly to two groups respectively. Group 1 is the experimental group for Transcranial Magnetic Stimulation (TMS) and trunk rotation; Group 2 is the control group with only trunk rotation training and placebo stimulation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

4.6 years

First QC Date

August 10, 2015

Last Update Submit

October 15, 2020

Conditions

Stroke

Keywords

transcranial magnetic stimulationtrunk rotation

Outcome Measures

Primary Outcomes (1)

  • Change score in Behaviorial Inattention Test (BIT) - Chinese version

    assessment for unilateral neglect

    Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks), 4 weeks follow up after last session of treatment

Secondary Outcomes (5)

  • Change score in Catherine Bergego Scale

    Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks), 4 weeks follow up after last session of treatment

  • Change score in FTHUE-HK

    Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks), 4 weeks follow up after last session of treatment

  • Change score in UE-Fugl Meyer

    Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks), 4 weeks follow up after last session of treatment

  • Change score in FIM

    Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks time), 4 weeks follow up after last session of treatment

  • Change score in SA-SIP 30

    Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks), 4 weeks follow up after last session of treatment

Study Arms (2)

TMS and trunk rotation

EXPERIMENTAL

TMS and trunk rotation

Device: TMS and trunk rotation

Sham TMS and trunk rotation

SHAM COMPARATOR

Sham TMS and trunk rotation

Device: Sham TMS and trunk rotation

Interventions

TMS and trunk rotationDEVICE

TMS and trunk rotation

TMS and trunk rotation
Sham TMS and trunk rotationDEVICE

Sham TMS and trunk rotation

Sham TMS and trunk rotation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • First or second stroke (haemorrhagic or ischaemic) confirmed by computer axial tomography scan or magnetic resonance imaging
  • Neurological representation compatible with a unilateral right lesion involvement (i.e. left hemiplegic), exhibited left visual field inattention or neglect by following either one of below criteria:
  • obtaining a total score of star cancellation subtest in the conventional battery of the Behavioural Inattention Test \<51 (out of 54)
  • obtaining a total score of line bisection subtest in the conventional battery of the Behavioural Inattention Test \<7 (out of 9)
  • Score of Catherine Bergego Scale ≥ 1
  • Right handed
  • Less than six months since onset of stroke at study entry
  • Able to follow simple command

You may not qualify if:

  • Patients with severe dysphasia (either expressive or comprehensive) which restricts communication;
  • History of other neurological disease, psychiatric disorder, or alcoholism;
  • significant impairment in visual acuity caused by cataracts, diabetic retinopathy, glaucoma or hemianopia
  • Any additional medical or psychological condition that would affect their ability to comply with the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kowloon Hospital

Kowloon, Hong Kong

Location

Related Publications (3)

  • Fong KN, Chan MK, Ng PP, Tsang MH, Chow KK, Lau CW, Chan FS, Wong IP, Chan DY, Chan CCh. The effect of voluntary trunk rotation and half-field eye-patching for patients with unilateral neglect in stroke: a randomized controlled trial. Clin Rehabil. 2007 Aug;21(8):729-41. doi: 10.1177/0269215507076391.

    PMID: 17846073BACKGROUND

  • Cazzoli D, Muri RM, Schumacher R, von Arx S, Chaves S, Gutbrod K, Bohlhalter S, Bauer D, Vanbellingen T, Bertschi M, Kipfer S, Rosenthal CR, Kennard C, Bassetti CL, Nyffeler T. Theta burst stimulation reduces disability during the activities of daily living in spatial neglect. Brain. 2012 Nov;135(Pt 11):3426-39. doi: 10.1093/brain/aws182. Epub 2012 Jul 24.

    PMID: 22831781RESULT

  • Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.

    PMID: 34196963DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Eric Yeung, MBChB

    Kowloon Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational Therapist, PhD Candidate

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 18, 2015

Study Start

August 1, 2015

Primary Completion

March 1, 2020

Study Completion

October 1, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations

HK(1)