Changes in Brain Activity Associated With Upper Limb Motor Recovery

NCT02325427 | Terminated DMC

• 1 other identifier: TMS2014/00358
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to investigate changes in brain activities in acute stroke patients , and to correlate findings with clinical outcome measures. Another aim of the study is to investigate whether transcranial direct current stimulation (tDCS) could improve motor function in subjects with poor brain activity after stroke. The brain activity will be measured by single and paired pulse TMS (transcranial magnetic stimulation). The study hypothesizes that:

1. 1.The neural mechanisms employed in patients who have different response to TMS stimulation are different. It is hypothesized that patients with no response upon TMS stimulation might have poorer motor function outcome, compared with patients with response upon TMS stimulation.
2. 2.The result of clinical outcome measures is related with TMS measurement.
3. 3.tDCS intervention is beneficial to subjects with poor brain activity. Clinical outcome measures will include a battery of upper limb motor tests such as upper extremity component of the Fugl-Meyer Assessment, Modified Ashworth scale for spasticity, box and block test, and manual muscle testing. Clinical outcome and TMS measurement will be assessed at within 2 weeks, 4-6 weeks and at 6 months post-stroke.

Conditions

Stroke

Keywords

stroke; rehabilitation; upper limb; TMS; tDCS

Outcome Measures

Primary Outcomes (1)

• Change of TMS (transcranial magnetic stimulation) measurement of cortical excitability

  within 1 month from stroke, 6-8 weeks post-stroke, 6 months post-stroke

Secondary Outcomes (4)

• Change of upper limb motor function in terms of Modified Ashworth scale for spasticity

  within 1 month from stroke, 6-8 weeks post-stroke, 6 months post-stroke

• Change of upper limb motor function in terms of Manual muscle testing

  within 1 month from stroke, 6-8 weeks post-stroke, 6 months post-stroke

• Change of upper limb motor function in terms of Box and block test

  within 1 month from stroke, 6-8 weeks post-stroke, 6 months post-stroke

• Change of upper limb motor function in terms of Fugl-Meyer Assessment

  within 1 month from stroke, 6-8 weeks post-stroke, 6 months post-stroke

Study Arms (3)

real tDCS

EXPERIMENTAL

Subjects will receive tDCS stimulation at the intensity of 1 mA and last for 20 minutes. The anode will be placed over the affected primary motor cortex (M1) of cortical representation of the hand, while the cathode will be used as reference electrode and placed over the forehead of the unaffected side.

Device: tDCS

sham tDCS

SHAM COMPARATOR

Subjects will receive sham tDCS stimulation. The same stimulation parameters as tDCS treatment will be employed for the sham stimulation. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation.

Device: tDCS

no stimulation

NO INTERVENTION

Subjects will not received any intervention.

Interventions

tDCS DEVICE

tDCS could deliver either real or sham stimulation.

real tDCS; sham tDCS

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 21-80 years;
• First ever haemorrhagic or ischaemic hemiplegic stroke less than 1 month prior to study enrollment;
• Upper extremity impairment of 0-45 out of a maximum score of 66 on the Fugl-Meyer assessment scale.
• MMSE\>=24.
• Be able to provide informed consent.

You may not qualify if:

• pregnancy; cardiac pacemakers; orthodontics (braces); metal implant; history of epilepsy; sensorimotor disturbance due to other causes other than stroke; uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina; major depression and a history of psychotic disorders.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (1)

• Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

  PMID: 33175411 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Effie Chew, MD

  National University Hospital, Singapore

  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: SPONSOR

Study Record Dates

• First Submitted: December 21, 2014
• First Posted: December 25, 2014
• Study Start: November 1, 2014
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

SG (1)