HemianopiaPhase 1/2NCT02935413
Combined tDCS and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study
A Phase 1/2 study testing tDCS and Standard rehabilitation in people with Hemianopia and Stroke, run by University of Magdeburg at 2 sites in 2 countries.
Trial summary
The purpose of this Study is to determine whether non-invasive transcranial direct current stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual Cortex. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemianopia, Stroke
- What is being tested?
- tDCS and Standard rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2013to Dec 2013
- Phase
- Phase 1/2
- 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
- Posterior Cerebral Artery Stroke
- Visual Field Defect
- Lesion age 4 weeks up to 6 month max
Who cannot join
- Electrical Implants
- Metal artefacts in head
- Epilepsy
- Visual Neglect
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Inst. f. Medical Psychology, Univ. of Magdeburg
Magdeburg, 39120
About this study
The purpose of this Study is to determine whether non-invasive transcranial direct current stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual Cortex.
Read the detailed description
Visual field defects after posterior cerebral artery stroke can be improved by vision restoration training (VRT), but when combined with transcranial direct current stimulation (tDCS) which alters brain excitability, vision restoration can be potentiated in the chronic stage. Because it is possible that such therapy may be more effective during the early recovery phase after the stroke and can reach patients during the rehabilitation phase, investigators wished to explore the applicability, efficacy and safety of early intervention with a combined tDCS/VRT treatment.
Seven post-acute stroke homonymous hemianopia patients were assigned to 10 sessions of combined tDCS (2mA, 10 daily sessions of 15-20 min) and VRT. The primary outcome criterion was the pre-post change in perimetric detection thresholds in percent. The results were compared to 7 age and stroke lesion matched controls of our patient data pool who received standard rehabilitation.
- Conditions
- Hemianopia, Stroke
- Being tested
- tDCS, Standard rehabilitation
- Medical subject headings
- Hemianopsia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Device: verum tDCS real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes Behavioral: VRT Vision restoration training, 10 sessions, 20 minutes
Standard rehabilitationBehavioural
Standard rehabilitation procedures involving PC-based training of saccades and visual exploration
| Study group | Role | What they receive |
|---|---|---|
| tDCS | Active comparator | group receiving complete treatment of transcranial direct current stimulation Receives: Device: tDCS |
| Standard rehabilitation | Active comparator | Standard rehabilitation procedures Receives: Behavioral: Standard rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention
Measured: 14-20 days post treatment,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionDec 2013
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 HemianopiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Collaborators
- Neurologisches Therapiezentrum Gmundnerberg
- Responsible party
- Principal investigator, Bernhard A. Sabel, University of Magdeburg
- Investigators
- Raimund Alber, MS, Principal investigator, Neurologisches Therapiezentrum Gmundnerberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935413
- Sponsor's protocol ID
- CES_NTG_Pilot
- Status last verified
- Oct 2016
- First submitted
- 13 Oct 2016
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Alber R, Moser H, Gall C, Sabel BA. Combined Transcranial Direct Current Stimulation and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study. PM R. 2017 Aug;9(8):787-794. doi: 10.1016/j.pmrj.2016.12.003. Epub 2017 Jan 8.
PubMed 28082176
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined tDCS and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study
- ClinicalTrials.gov ID
- NCT02935413
- Acronym / sponsor ID
- CES_NTG_Pilot
- Conditions
- Hemianopia, Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Collaborators
- Neurologisches Therapiezentrum Gmundnerberg
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Oct 2016 (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 non-invasive transcranial direct current stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual Cortex.
Detailed description
Visual field defects after posterior cerebral artery stroke can be improved by vision restoration training (VRT), but when combined with transcranial direct current stimulation (tDCS) which alters brain excitability, vision restoration can be potentiated in the chronic stage. Because it is possible that such therapy may be more effective during the early recovery phase after the stroke and can reach patients during the rehabilitation phase, investigators wished to explore the applicability, efficacy and safety of early intervention with a combined tDCS/VRT treatment.
Seven post-acute stroke homonymous hemianopia patients were assigned to 10 sessions of combined tDCS (2mA, 10 daily sessions of 15-20 min) and VRT. The primary outcome criterion was the pre-post change in perimetric detection thresholds in percent. The results were compared to 7 age and stroke lesion matched controls of our patient data pool who received standard rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS | Active comparator | Device: tDCSgroup receiving complete treatment of transcranial direct current stimulation |
| Standard rehabilitation | Active comparator | Behavioral: Standard rehabilitationStandard rehabilitation procedures |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Posterior Cerebral Artery Stroke
- Visual Field Defect
- Lesion age 4 weeks up to 6 month max
Key exclusion criteria (4 listed)
- Electrical Implants
- Metal artefacts in head
- Epilepsy
- Visual Neglect
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 |
|---|---|---|
| tDCSDevice: verum tDCS real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes Behavioral: VRT Vision restoration training, 10 sessions, 20 minutes | Device | tDCS |
| Standard rehabilitationStandard rehabilitation procedures involving PC-based training of saccades and visual exploration | Behavioural | Standard rehabilitation |
Primary outcome
Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention
Time frame: 14-20 days post treatment,
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 17 Oct 2016.
- Derived from this study: PubMed 28082176Alber R, Moser H, Gall C, Sabel BA. Combined Transcranial Direct Current Stimulation and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study. PM R. 2017 Aug;9(8):787-794. doi: 10.1016/j.pmrj.2016.12.003. Epub 2017 Jan 8.
- Individual participant dataSharing planned: No
Related trials for Hemianopia
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Not yet recruiting
Multisensory Rehabilitation of Vision Loss After Cortical Damage
Cortical Blindness
Recruiting
Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Hemianopia, Homonymous, Cortical Blindness, Unspecified Side of Brain
Active, not recruiting
Statistical Learning as a Novel Intervention for Cortical Blindness
Stroke, Ischemic, Hemianopia, Homonymous
Not yet recruitingObservational study
Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia
Homonymous Hemianopia, Stroke
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.
Raimund Alber, MS principal investigator
Neurologisches Therapiezentrum Gmundnerberg
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing tDCS and Standard rehabilitation in people with Hemianopia and Stroke, run by University of Magdeburg at 2 sites in 2 countries.
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 3 inclusion and 4 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 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Germany. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 mean sensitivity (in dB) detection threshold from baseline to post-intervention (time frame: 14-20 days post treatment,). 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 NCT02935413, 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 17 Oct 2016.