CClinicalTrials.gg
Status unknownNCT01356654Updated May 19, 2011

Transcranial Direct Current Stimulation in Stroke Rehabilitation

An interventional study of Application of Transcranial direct current stimulation (TDCS) and Transcranial Direct current stimulation in Stroke, sponsored by Universiteit Antwerpen. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-05-19.

Sponsored by Universiteit Antwerpen · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This study investigates if transcranial Direct Current Stimulation (tDCS) is effective in the recovery of postural control in stroke rehabilitation.

Read the detailed description

The patients were divided in 2 groups by a randomisation procedure. All patients participated for 2 months in the study. Group 1 received true tDCS in the first month followed by SHAM stimulation in the second month. Group 2 received SHAM in the first month and true stimulation in the following month. Four stimulations of 20minutes were provided during 4 weeks before before changing stimulation intensity.

02

Conditions studied

  • Stroke

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Keywords

  • Stroke
  • TDCS
  • Gait
  • Balance
  • loss of postural balance
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 34 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Universiteit Antwerpen is the lead sponsor of 128 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients suffering from the consequences of a stroke in the medial cerebral artery, during the sub-acute phase (4-24 weeks after onset)
  2. Age between 18-75 years
  3. Hospitalised in rehabilitation Hospital Hof Ter Schelde
  4. Capable of understanding and giving informed consent

Exclusion criteria

Exclusion Criteria:

  1. Cerebellum or brainstem lesions
  2. Recently multiple lesions and older lesions which are manifested clinically.
  3. History of severe substance abuse (alcohol, drugs, benzodiazepines)
  4. Cardiac disease that in the opinion of the clinician precludes participation in the trial (severe dyspnea in rest, severe rhythm disturbances, etc)
  5. History of epileptic insults, not caused by the stroke
  6. Severe organic co morbidity
  7. Psychiatric disorders or history of psychiatric disorders
  8. Pace maker / internal defibrillator
  9. Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
34 participants (estimated)

Study arms

  • Sham comparator
    SHAM TDCS

    Device: Application of Transcranial direct current stimulation (TDCS)

  • Active comparator
    True TDCS

    Device: Transcranial Direct current stimulation

Interventions

  • DeviceApplication of Transcranial direct current stimulation (TDCS)

    Application of TDCS for 20 minutes, 4 times a week for 4 weeks.

    Also known as: tDCS device: CESta, Mind Alive Inc.,Edmonton, Alberta, Canada

  • DeviceTranscranial Direct current stimulation

    Application of true TDCS for 20min, 4 times a week for 4 weeks.

    Also known as: tDCS device: CESta, Mind Alive Inc., Edmonton, Alberta, Canada

06

What researchers measure

Primary outcomes

  1. Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months)

    The static sitting balance subscale assesses whether a subject can sit independently and remain seated when the legs are either passively or actively crossed. The dynamic sitting balance subscale evaluates the ability to actively shorten each side of the trunk, first initiated from the shoulder and subsequently initiated from the pelvic girdle. Trunk coordination is evaluated by the possibility to independently rotate the upper and lower part of the trunk. The scoring range for the static and dynamic sitting balance and coordination subscales are 7, 10 and 6 points respectively.

    Time frame: baseline, after 1 month, After 2 months

  2. Rivermead Motor Assessment Battery (RMAB) (reporting a change on motricity of gross function, arm, leg and trunk at baseline, after 1 month and after two months)

    The RMAB assesses the motor performance of patients with stroke.32 It consists of test items clustered in three sections that are ordered hierarchically. The gross function subscale (13 items), the Leg and Trunk subscale (10 items) and the arm subscale (15 items)

    Time frame: baseline, after 1 month, After 2 months

  3. Tinetti Test (reporting a change on balance and gait tasks at baseline, after 1 month and after two months)

    The Tinetti Test is an easily performed test that measures a patients' gait and balance. The individual scores are combined to form three measures; a gait score, a standing balance score and a total score. The maximum score for the gait component and the balance component are 12 and 16 points respectively, resulting in a maximum of 28 points for the total score.

    Time frame: baseline, after 1 month, After 2 months

07

Study locations

1 of 1 sites recruiting
  • Rehabilitation Hospital Hof Ter Schelde
    Antwerp, 2050, Belgium
    • Wim Saeys, MSc · Contact · wim.saeys@hotmail.com · 032106020
    • Wim Saeys, Msc · Principal investigator
    • Luc Vereeck, PhD · Sub investigator
    • Christophe Lafosse, PhD · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 33175411 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01356654
Lead sponsor
Universiteit Antwerpen
Collaborators
Rehabilitation Hospital Hof Ter Schelde, Artesis University College, Antwerp
First posted
May 19, 2011
Start date
Mar 2010
Primary completion
Jun 2011 (estimated)
Completion
Jun 2011 (estimated)
Last update
May 19, 2011

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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