Transcranial Direct Current StimulationNCT02210403
The Influence of tDCS on the Arm and Hand Function in Stroke Patients
A study testing transcranial direct current stimulation (tDCS) in people with Transcranial Direct Current Stimulation and Cerebrovascular Accident (CVA), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The purpose of this study is to determine whether tDCS in combination with motor training can improve hand and arm function in stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcranial Direct Current Stimulation, Cerebrovascular Accident (CVA)
- What is being tested?
- transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Apr 2013to 28 Sep 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke patients onset > 6 months
- First ever stroke
- Decreased hand and arm function
- Mini Mental State Examination (>24)
Who cannot join
- Depression
- Pregnancy
- Alcohol abuse
- Aneurysm clips
- Pacemaker
- Neurostimulator
Show all 19Show fewer
- Implemented defibrillator
- Magnetically activated implant or device
- implemented pump
- Spinal cord simulator
- Implemented hearing aid
- Artificial or prosthetic limb
- Metal parts in the body
- Any external or internal metal
- Artificial heart valve
- Other implants
- History of brain surgery
- Migraine
- Family history of Epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether tDCS in combination with motor training can improve hand and arm function in stroke patients.
- Being tested
- transcranial direct current stimulation (tDCS)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS)Device
| Study group | Role | What they receive |
|---|---|---|
| Upper limb motor function training + tDCS | Active comparator | Bi-hemispheric tDCS with motor function training Receives: Device: transcranial direct current stimulation (tDCS) |
| upper limb motor function training + sham tDCS | Sham comparator | sham tDCS with motor function training Receives: Device: transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Fugl-Meyer assessment (FMA) score
Measured: Change from baseline in FMA score on the 3rd intervention day; change from baseline in FMA score at 1 week post intervention
Secondary outcomes (1)
Change of Modified Ashworth scale (MAS)
Measured: Change from baseline in MAS scale on the 3rd intervention day; change from baseline in MAS scale at 1 week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study start18 Apr 2013
- Primary completion28 Sep 2014
- Study completion28 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transcranial Direct Current StimulationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210403
- Sponsor's protocol ID
- S54797
- Status last verified
- Feb 2013
- First submitted
- 24 Jul 2014
- Last updated
- 28 Mar 2023
- Results posted
- No
Publications
Zhang X, Meesen R, Swinnen SP, Feys H, Woolley DG, Cheng HJ, Wenderoth N. Combining muscle-computer interface guided training with bihemispheric tDCS improves upper limb function in patients with chronic stroke. J Neurophysiol. 2024 Jun 1;131(6):1286-1298. doi: 10.1152/jn.00316.2023. Epub 2024 May 8.
PubMed 38716555Elsner 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 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of tDCS on the Arm and Hand Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT02210403
- Acronym / sponsor ID
- S54797
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 18 Apr 2013
- Primary completion
- 28 Sep 2014 (actual)
- Study completion
- 28 Sep 2014 (actual)
- First posted
- 6 Aug 2014 (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.
The purpose of this study is to determine whether tDCS in combination with motor training can improve hand and arm function in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper limb motor function training + tDCS | Active comparator | Device: transcranial direct current stimulation (tDCS)Bi-hemispheric tDCS with motor function training |
| upper limb motor function training + sham tDCS | Sham comparator | Device: transcranial direct current stimulation (tDCS)sham tDCS with motor function training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stroke patients onset > 6 months
- First ever stroke
- Decreased hand and arm function
- Mini Mental State Examination (>24)
Key exclusion criteria (19 listed)
- Depression
- Pregnancy
- Alcohol abuse
- Aneurysm clips
- Pacemaker
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 |
|---|---|---|
| transcranial direct current stimulation (tDCS) | Device | Upper limb motor function training + tDCS, upper limb motor function training + sham tDCS |
Primary outcome
Change of Fugl-Meyer assessment (FMA) score
Time frame: Change from baseline in FMA score on the 3rd intervention day; change from baseline in FMA score at 1 week post intervention
1 secondary outcome
Change of Modified Ashworth scale (MAS)
Time frame: Change from baseline in MAS scale on the 3rd intervention day; change from baseline in MAS scale at 1 week post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Derived from this study: PubMed 38716555Zhang X, Meesen R, Swinnen SP, Feys H, Woolley DG, Cheng HJ, Wenderoth N. Combining muscle-computer interface guided training with bihemispheric tDCS improves upper limb function in patients with chronic stroke. J Neurophysiol. 2024 Jun 1;131(6):1286-1298. doi: 10.1152/jn.00316.2023. Epub 2024 May 8.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) in people with Transcranial Direct Current Stimulation and Cerebrovascular Accident (CVA), run by Universitaire Ziekenhuizen KU Leuven 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 19 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: finished, as of the sponsor's last update on 28 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Fugl-Meyer assessment (FMA) score (time frame: Change from baseline in FMA score on the 3rd intervention day; change from baseline in FMA score at 1 week post intervention). 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 NCT02210403, which also lists 2 linked publications.
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 28 Mar 2023.