StrokeNCT00783913
Using Transcranial Direct Current Stimulation (tDCS) to Enhance the Benefit of Movement Training in Stoke Patients
A study testing Visumotor Upper Extremity Training in people with Stroke, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will determine if electrical brain stimulation during movement practice can improve the ability of stroke patients to reach for objects more than movement practice alone. People between 18 and 85 years old who have had a stroke may be eligible for this study. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Visumotor Upper Extremity Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2008to 24 Oct 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 85 years.
- Ability to sit and be active for an hour on a chair (or wheelchair) without cardiac, respiratory and/or pain disturbances as assessed during the screening visit.
- Willingness to commit to participate in the long-term follow-up study (up to 3 months)
- Willingness to give written informed consent.
- Diagnosis of a first clinically apparent unilateral cortical or subcortical stroke at least 3 months prior to study entry
Who cannot join
- History of severe neurological illness (e.g. brain tumor, epilepsy or acute seizures, polyneuropathy etc.) or severe cognitive impairment (MMSE less than 23)
- MRI contraindications. (Cardiac pacemakers; Intracardiac lines; Implanted medication pumps; Neural stimulators; blood vessel, cochlear, or eye implants; Metal in the cranium except in the mouth; Dental braces; Metal fragments from occupational exposure; Surgical clips in or near the brain).
- History of alcohol or drug abuse
- Active depression of any severity with psychoactive medication changes in the last 2 months, active psychosis, disruptive or violent behavior, poor motivational capacity as assessed by the study physician by patient questioning
- Aphasia or language disturbances that would interfere with performing the study tasks
- Uncontrolled medical problems (e.g., active cancer or renal disease, any type of end-stage pulmonary or cardiovascular disease, diabetes, or other medical conditions, as determined by the study physician, that would interfere with participation in this study).
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- Increased intracranial pressure as evaluated by clinical means (fundoscopic exam).
- Severe neglect or ataxia that would interfere in the completion of the study tasks.
- History of more than one stroke or a stroke that affects both sides of the brain, the brainstem, or the cerebellum.
- Inflammation of the tissue, severe rheumatoid arthritis, or abnormal function of the joints due to arthritis in the affected arm used most often.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Enhancing the Beneficial Effects of Upper Extremity Visuomotor Training With tDCS
This study will determine if electrical brain stimulation during movement practice can improve the ability of stroke patients to reach for objects more than movement practice alone.
People between 18 and 85 years old who have had a stroke may be eligible for this study. Participants are randomly assigned to one of two study groups: movement training with active (tDCS) or movement training with sham (tDCS).
Read more
Participants will undergo 1-hour movement training and (tDCS) sessions twice a day, 5 days a week, for 3 weeks. For these sessions, subjects will sit in front of a computer screen that shows a target (round dots) and a cursor (a line). Participants will be instructed to move the cursor to various targets on the computer screen as fast and as accurately as possible, controlling the position of the cursor by moving their arm, which will rest on a mechanical device.
Participants will receive real or sham (tDCS) during the movement training sessions. For (tDCS), electrode sponges soaked in tap water are placed on the scalp and forehead. A small electrical current is passed between the electrodes. The stimulation lasts 20 minutes.
Patients will have the following tests four times during the study - 1) before starting movement training 2) (tDCS) during the course of training and (tDCS), 3) after completing training and (tDCS), 4) and 3 months after completing training and (tDCS):
Functional magnetic resonance imaging (fMRI)
Magnetic resonance imaging (MRI) uses a magnetic field and radio waves to take pictures of the brain. Functional MRI (fMRI) shows what parts of the brain are used when a task is performed. For the test, the subject lies on a table that can slide in and out of the scanner. A computer screen can be seen from inside the scanner. During the scan, subjects may be asked to do the study task or to lie still for up to 20 minutes at a time.
Movement and function tests
- Measurement of arm stiffness
- Moving the arms actively and against resistance
- Picking up objects and moving them as quickly as possible
- Performing daily living tasks like buttoning, dressing and walking
- Performing tasks while wearing a glove that monitors the position of the arm
- Completing questionnaires on ability to perform daily activities or other movements and level of tiredness
Transcranial magnetic stimulation (TMS)
TMS uses a magnet to stimulate the brain in way that is different from (tDCS). This study us...
Read the detailed description
Individuals who have suffered a stroke may benefit from the development of new rehabilitative interventions that can improve motor recovery after a stroke.
Objective:
The objective of this protocol is to test the hypothesis that active training on a complex upper extremity visuomotor task combined with anodal transcranial direct current stimulation (tDCS) used to activate the affected hemisphere improves functionality during reaching of the affected upper-extremity in comparison to training combined with sham tDCS in stroke patients.
The Study population:
The study population will include chronic (more than 3 months) stroke patients.
Design:
The study will follow a factorial design in which all subjects will undergo several sessions of complex visuomotor task training of the upper extremity. One half of the patients will undergo anodal transcranial direct current stimulation during the first 20 minutes of each training session, while the control subjects will have sham stimulation applied.
Outcome Measures:
The primary outcome measure for the study is accuracy during completion of a reaching task. The primary endpoint for the study will be the end of 3 weeks of training (15 days). Secondary endpoint measures include timing of reach, kinematic, and functional measures. These measures will be taken at the end of training and at a 3 month follow-up.
- Conditions
- Stroke
- Being tested
- Visumotor Upper Extremity Training, Anodal/Sham tDCS
- Keywords
- Direct Current Stimulation, Rehabilitation, Motor Learning, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visumotor Upper Extremity TrainingOther
Control
Anodal/Sham tDCSOther
Condition
What is being measured
The primary outcome is the main question the study is designed to answer.
Will include the accuracy (defined as the difference between the straight line connecting the origin and the target and the line followed by the subject) during reaching. One of the additional outcomes is the time to complete a reaching task.
Secondary outcomes (1)
The Fugl-Meyer assessment is a widely used cumulative numeric rating tool that assesses motor impairment. The maximum score for the upper extremity is 66. The uFM test measures both proximal and distal upper extremity movements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study start29 Oct 2008
- Primary completion24 Oct 2011
- Study completion24 Oct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Factorial
- Masking
- Double blind
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783913
- Sponsor's protocol ID
- 090021
- Other IDs
- 09-N-0021
- Status last verified
- 24 Oct 2011
- First submitted
- 31 Oct 2008
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Jorgensen HS, Nakayama H, Raaschou HO, Larsen K, Hubbe P, Olsen TS. The effect of a stroke unit: reductions in mortality, discharge rate to nursing home, length of hospital stay, and cost. A community-based study. Stroke. 1995 Jul;26(7):1178-82. doi: 10.1161/01.str.26.7.1178.
PubMed 7604410Jorgensen HS, Nakayama H, Raaschou HO, Vive-Larsen J, Stoier M, Olsen TS. Outcome and time course of recovery in stroke. Part I: Outcome. The Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 May;76(5):399-405. doi: 10.1016/s0003-9993(95)80567-2.
PubMed 7741608Lincoln NB, Parry RH, Vass CD. Randomized, controlled trial to evaluate increased intensity of physiotherapy treatment of arm function after stroke. Stroke. 1999 Mar;30(3):573-9. doi: 10.1161/01.str.30.3.573.
PubMed 10066854Elsner 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 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Beneficial Effects of Upper Extremity Visuomotor Training With tDCS
- ClinicalTrials.gov ID
- NCT00783913
- Acronym / sponsor ID
- 090021
- Conditions
- Stroke
- Keywords
- Direct Current Stimulation, Rehabilitation, Motor Learning, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 29 Oct 2008
- Primary completion
- 24 Oct 2011 (actual)
- Study completion
- 24 Oct 2011 (actual)
- First posted
- 3 Nov 2008 (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 will determine if electrical brain stimulation during movement practice can improve the ability of stroke patients to reach for objects more than movement practice alone.
People between 18 and 85 years old who have had a stroke may be eligible for this study. Participants are randomly assigned to one of two study groups: movement training with active (tDCS) or movement training with sham (tDCS).
Participants will undergo 1-hour movement training and (tDCS) sessions twice a day, 5 days a week, for 3 weeks. For these sessions, subjects will sit in front of a computer screen that shows a target (round dots) and a cursor (a line). Participants will be instructed to move the cursor to various targets on the computer screen as fast and as accurately as possible, controlling the position of the cursor by moving their arm, which will rest on a mechanical device.
Participants will receive real or sham (tDCS) during the movement training sessions. For (tDCS), electrode sponges soaked in tap water are placed on the scalp and forehead. A small electrical current is passed between the electrodes. The stimulation lasts 20 minutes.
Patients will have the following tests four times during the study - 1) before starting movement training 2) (tDCS) during the course of training and (tDCS), 3) after completing training and (tDCS), 4) and 3 months after completing training and (tDCS):
Functional magnetic resonance imaging (fMRI)
Magnetic resonance imaging (MRI) uses a magnetic field and radio waves to take pictures of the brain. Functional MRI (fMRI) shows what parts of the brain are used when a task is performed. For the test, the subject lies on a table that can slide in and out of the scanner. A computer screen can be seen from inside the scanner. During the scan, subjects may be asked to do the study task or to lie still for up to 20 minutes at a time.
Movement and function tests
- Measurement of arm stiffness
- Moving the arms actively and against resistance
- Picking up objects and moving them as quickly as possible
- Performing daily living tasks like buttoning, dressing and walking
- Performing tasks while wearing a glove that monitors the position of the arm
- Completing questionnaires on ability to perform daily activities or other movements and level of tiredness
Transcranial magnetic stimulation (TMS)
TMS uses a magnet to stimulate the brain in way that is different from (tDCS). This study us...
Detailed description
Individuals who have suffered a stroke may benefit from the development of new rehabilitative interventions that can improve motor recovery after a stroke.
Objective:
The objective of this protocol is to test the hypothesis that active training on a complex upper extremity visuomotor task combined with anodal transcranial direct current stimulation (tDCS) used to activate the affected hemisphere improves functionality during reaching of the affected upper-extremity in comparison to training combined with sham tDCS in stroke patients.
The Study population:
The study population will include chronic (more than 3 months) stroke patients.
Design:
The study will follow a factorial design in which all subjects will undergo several sessions of complex visuomotor task training of the upper extremity. One half of the patients will undergo anodal transcranial direct current stimulation during the first 20 minutes of each training session, while the control subjects will have sham stimulation applied.
Outcome Measures:
The primary outcome measure for the study is accuracy during completion of a reaching task. The primary endpoint for the study will be the end of 3 weeks of training (15 days). Secondary endpoint measures include timing of reach, kinematic, and functional measures. These measures will be taken at the end of training and at a 3 month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 85 years.
- Ability to sit and be active for an hour on a chair (or wheelchair) without cardiac, respiratory and/or pain disturbances as assessed during the screening visit.
- Willingness to commit to participate in the long-term follow-up study (up to 3 months)
- Willingness to give written informed consent.
- Diagnosis of a first clinically apparent unilateral cortical or subcortical stroke at least 3 months prior to study entry
Key exclusion criteria (11 listed)
- History of severe neurological illness (e.g. brain tumor, epilepsy or acute seizures, polyneuropathy etc.) or severe cognitive impairment (MMSE less than 23)
- MRI contraindications. (Cardiac pacemakers; Intracardiac lines; Implanted medication pumps; Neural stimulators; blood vessel, cochlear, or eye implants; Metal in the cranium except in the mouth; Dental braces; Metal fragments from occupational exposure; Surgical clips in or near the brain).
- History of alcohol or drug abuse
- Active depression of any severity with psychoactive medication changes in the last 2 months, active psychosis, disruptive or violent behavior, poor motivational capacity as assessed by the study physician by patient questioning
- Aphasia or language disturbances that would interfere with performing the study tasks
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 |
|---|---|---|
| Visumotor Upper Extremity TrainingControl | Other | – |
| Anodal/Sham tDCSCondition | Other | – |
Primary outcome
Will include the accuracy (defined as the difference between the straight line connecting the origin and the target and the line followed by the subject) during reaching. One of the additional outcomes is the time to complete a reaching task.
1 secondary outcome
The Fugl-Meyer assessment is a widely used cumulative numeric rating tool that assesses motor impairment. The maximum score for the upper extremity is 66. The uFM test measures both proximal and distal upper extremity movements.
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 2 Jul 2017.
- Background: PubMed 7604410Jorgensen HS, Nakayama H, Raaschou HO, Larsen K, Hubbe P, Olsen TS. The effect of a stroke unit: reductions in mortality, discharge rate to nursing home, length of hospital stay, and cost. A community-based study. Stroke. 1995 Jul;26(7):1178-82. doi: 10.1161/01.str.26.7.1178.
- Background: PubMed 7741608Jorgensen HS, Nakayama H, Raaschou HO, Vive-Larsen J, Stoier M, Olsen TS. Outcome and time course of recovery in stroke. Part I: Outcome. The Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 May;76(5):399-405. doi: 10.1016/s0003-9993(95)80567-2.
- Background: PubMed 10066854Lincoln NB, Parry RH, Vass CD. Randomized, controlled trial to evaluate increased intensity of physiotherapy treatment of arm function after stroke. Stroke. 1999 Mar;30(3):573-9. doi: 10.1161/01.str.30.3.573.
- 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 Visumotor Upper Extremity Training in people with Stroke, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
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 5 inclusion and 11 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 2 Jul 2017. 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 United States. 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. 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?
Will include the accuracy (defined as the difference between the straight line connecting the origin and the target and the line followed by the subject) during reaching. One of the additional outcomes is the time to complete a reaching task.. 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 NCT00783913, which also lists 4 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 2 Jul 2017.