StrokeNCT01356654
Transcranial Direct Current Stimulation in Stroke Rehabilitation
A study testing Application of Transcranial direct current stimulation (TDCS) and Transcranial Direct current stimulation in people with Stroke, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
This study investigates if transcranial Direct Current Stimulation (tDCS) is effective in the recovery of postural control in stroke rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Application of Transcranial direct current stimulation (TDCS) and Transcranial Direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from the consequences of a stroke in the medial cerebral artery, during the sub-acute phase (4-24 weeks after onset)
- Age between 18-75 years
- Hospitalised in rehabilitation Hospital Hof Ter Schelde
- Capable of understanding and giving informed consent
Who cannot join
- Cerebellum or brainstem lesions
- Recently multiple lesions and older lesions which are manifested clinically.
- History of severe substance abuse (alcohol, drugs, benzodiazepines)
- Cardiac disease that in the opinion of the clinician precludes participation in the trial (severe dyspnea in rest, severe rhythm disturbances, etc)
- History of epileptic insults, not caused by the stroke
- Severe organic co morbidity
Show all 9Show fewer
- Psychiatric disorders or history of psychiatric disorders
- Pace maker / internal defibrillator
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Rehabilitation Hospital Hof Ter Schelde
Antwerp, Antwerp, 2050
Wim Saeys, MSc, 032106020, wim.saeys@hotmail.com
Wim Saeys, Msc
About this study
Official title: The Use of Transcranial Direct Current Stimulation in the Recovery of Postural Control in Stroke
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.
- Conditions
- Stroke
- Being tested
- Application of Transcranial direct current stimulation (TDCS), Transcranial Direct current stimulation
- Keywords
- Stroke, TDCS, Gait, Balance, loss of postural balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Transcranial direct current stimulation (TDCS)Device
Also called tDCS device: CESta, Mind Alive Inc.,Edmonton, Alberta, Canada
Application of TDCS for 20 minutes, 4 times a week for 4 weeks.
Transcranial Direct current stimulationDevice
Also called tDCS device: CESta, Mind Alive Inc., Edmonton, Alberta, Canada
Application of true TDCS for 20min, 4 times a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SHAM TDCS | Sham comparator | Not described Receives: Device: Application of Transcranial direct current stimulation (TDCS) |
| True TDCS | Active comparator | Not described Receives: Device: Transcranial Direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, after 1 month, After 2 months
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)
Measured: baseline, after 1 month, After 2 months
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.
Measured: baseline, after 1 month, After 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startMar 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Rehabilitation Hospital Hof Ter Schelde, Artesis University College, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356654
- Sponsor's protocol ID
- Saeys-1
- Status last verified
- May 2011
- First submitted
- 10 May 2011
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Transcranial Direct Current Stimulation in the Recovery of Postural Control in Stroke
- ClinicalTrials.gov ID
- NCT01356654
- Acronym / sponsor ID
- Saeys-1
- Conditions
- Stroke
- Keywords
- Stroke, TDCS, Gait, Balance, loss of postural balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Rehabilitation Hospital Hof Ter Schelde, Artesis University College, Antwerp
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 19 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates if transcranial Direct Current Stimulation (tDCS) is effective in the recovery of postural control in stroke rehabilitation.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHAM TDCS | Sham comparator | Device: Application of Transcranial direct current stimulation (TDCS) |
| True TDCS | Active comparator | Device: Transcranial Direct current stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients suffering from the consequences of a stroke in the medial cerebral artery, during the sub-acute phase (4-24 weeks after onset)
- Age between 18-75 years
- Hospitalised in rehabilitation Hospital Hof Ter Schelde
- Capable of understanding and giving informed consent
Key exclusion criteria (9 listed)
- Cerebellum or brainstem lesions
- Recently multiple lesions and older lesions which are manifested clinically.
- History of severe substance abuse (alcohol, drugs, benzodiazepines)
- Cardiac disease that in the opinion of the clinician precludes participation in the trial (severe dyspnea in rest, severe rhythm disturbances, etc)
- History of epileptic insults, not caused by the stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of Transcranial direct current stimulation (TDCS)Also: tDCS device: CESta, Mind Alive Inc.,Edmonton, Alberta, CanadaApplication of TDCS for 20 minutes, 4 times a week for 4 weeks. | Device | SHAM TDCS |
| Transcranial Direct current stimulationAlso: tDCS device: CESta, Mind Alive Inc., Edmonton, Alberta, CanadaApplication of true TDCS for 20min, 4 times a week for 4 weeks. | Device | True TDCS |
Primary outcome
Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months)
Time frame: baseline, after 1 month, After 2 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.
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)
Time frame: baseline, after 1 month, After 2 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)
Tinetti Test (reporting a change on balance and gait tasks at baseline, after 1 month and after two months)
Time frame: baseline, after 1 month, After 2 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- Derived from this study: PubMed 33175411Elsner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of Transcranial direct current stimulation (TDCS) and Transcranial Direct current stimulation in people with Stroke, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months) (time frame: baseline, after 1 month, After 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01356654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.