StrokeNCT02525393
Transcranial Stimulation in Motor Stroke Rehabilitation
A study testing tDCS and rTMS in people with Stroke, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Patients were randomized in 3 groups: two intervent groups and a control group. The first group received two weeks of daily session of repetitive Transcranial Magnetic Stimulation (rTMS, 10 sessions) and, at least 6 months after, two weeks of daily transcranial Direct Current Stimulation (tDCS, 10 sessions); the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- tDCS and rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2012to Jul 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ischemic or hemorrhagic stroke (> 6 months from the accident)
Who cannot join
- general cognitive impairment (Mini Mental State Examination < 25), severe functional disability (Barthel Index < 45),
- psychiatric disorders,
- degenerative neurological disorders,
- epilepsy,
- severe medical conditions,
- having been implanted a drug infusion system, spinal/brain-stimulator, or endovascular coil
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Non Invasive Transcranial Brain Stimulation in Motor Stroke Rehabilitation
Patients were randomized in 3 groups: two intervent groups and a control group. The first group received two weeks of daily session of repetitive Transcranial Magnetic Stimulation (rTMS, 10 sessions) and, at least 6 months after, two weeks of daily transcranial Direct Current Stimulation (tDCS, 10 sessions); the second group received 10 daily session of tDCS and, after at least 6 months, 10 sessions of rTMS; the control group received 10 daily session of sham tDCS.
Physiatric evaluations (ARAT scale), neuropsychological assessment and ERP (P300) were performed before (1 week) and after (1 week) the end of each treatment. Furthermore, all patients underwent follow-up neuropsychological assessment 6 months after the end of each stimulation period and follow-up physiatric evaluation at 3 and 6 months after the end of each stimulation period.
- Conditions
- Stroke
- Keywords
- Rehabilitation, Non Invasive Brain Stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called HDC Stim device Newronica
Stroke rehabilitation performed with the aid of a transcranial electrical stimulation device.
rTMSDevice
Also called PowerMAG 100 MAG&More
Stroke rehabilitation performed with the aid of a repetitive transcranial magnetic stimulation device.
ShamDevice
Also called HDC Stim device Newronica
Stroke sham stimulation performed with the aid of a transcranial electrical stimulation device.
| Study group | Role | What they receive |
|---|---|---|
| tDCS+rTMS | Experimental | Stroke patients were treated with an initial two weeks of transcranial direct current stimulation and after six months with two weeks of repetitive transcranial magnetic stimulation. Receives: Device: tDCS; Device: rTMS |
| rTMS+tDCS | Experimental | Stroke patients were treated with an initial two weeks of repetitive transcranial magnetic stimulation and after six months with two weeks of transcranial direct current stimulation. Receives: Device: tDCS; Device: rTMS |
| Sham stimulation | Sham comparator | Stroke patients were treated with two weeks of sham transcranial direct current stimulation. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline ARAT (measures Grasp, Grip, Pinch, Gross Movement)
Action Research Arm Test (ARAT) measures Grasp, Grip, Pinch, Gross Movement. Baseline is 1 week before first treatment; other time frame: 1 week after first treatment; 3 months after first treatment; 6 months follow-up after first treatment; 1 week before second treatment; 1 week after second treatment; 3 months follow-up after second treatment; 6 months follow-up after second treatment.
Measured: Baseline; 1 month; 3 months; 6 months; 6 months and 1 week; 7 months; 9 months; 12 months
Secondary outcomes (2)
P300 (latency)
The P300 (P3) wave is an event related potential (ERP) component elicited in the process of decision making.
Investigators measured the latency of the component 1 week before first treatment; 1 week after first treatment; 1 week before second treatment; 1 week after second treatment.
Measured: Baseline; 1 month; 6 months and 1 week; 7 months
Cognition (standardized neuropsychological assessment)
The patients were evaluated by means of a standardized neuropsychological assessment consisting of a battery of cognitive tests involving the following domains: verbal short-term memory, visuospatial learning, working memory, verbal learning, attention and frontal executive functions, and general cognitive impairment.
The assessment was repeated 1 week before first treatment; 1 week after first treatment; 6 months follow-up after first treatment; 1 week before second treatment; 1 week after second treatment; 6 months follow-up after second treatment.
Measured: Baseline; 1 month; 6 months; 6 months and 1 week; 7 months; 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startMar 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Dagata, University of Turin, Italy
- Investigators
- Federico D'Agata, PhD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525393
- Sponsor's protocol ID
- CEI 339
- Status last verified
- Aug 2015
- First submitted
- 11 Aug 2015
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Non Invasive Transcranial Brain Stimulation in Motor Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT02525393
- Acronym / sponsor ID
- CEI 339
- Conditions
- Stroke
- Keywords
- Rehabilitation, Non Invasive Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 17 Aug 2015 (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.
Patients were randomized in 3 groups: two intervent groups and a control group. The first group received two weeks of daily session of repetitive Transcranial Magnetic Stimulation (rTMS, 10 sessions) and, at least 6 months after, two weeks of daily transcranial Direct Current Stimulation (tDCS, 10 sessions); the second group received 10 daily session of tDCS and, after at least 6 months, 10 sessions of rTMS; the control group received 10 daily session of sham tDCS.
Physiatric evaluations (ARAT scale), neuropsychological assessment and ERP (P300) were performed before (1 week) and after (1 week) the end of each treatment. Furthermore, all patients underwent follow-up neuropsychological assessment 6 months after the end of each stimulation period and follow-up physiatric evaluation at 3 and 6 months after the end of each stimulation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS+rTMS | Experimental | Device: tDCS, Device: rTMSStroke patients were treated with an initial two weeks of transcranial direct current stimulation and after six months with two weeks of repetitive transcranial magnetic stimulation. |
| rTMS+tDCS | Experimental | Device: tDCS, Device: rTMSStroke patients were treated with an initial two weeks of repetitive transcranial magnetic stimulation and after six months with two weeks of transcranial direct current stimulation. |
| Sham stimulation | Sham comparator | Device: ShamStroke patients were treated with two weeks of sham transcranial direct current stimulation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ischemic or hemorrhagic stroke (> 6 months from the accident)
Key exclusion criteria (6 listed)
- general cognitive impairment (Mini Mental State Examination < 25), severe functional disability (Barthel Index < 45),
- psychiatric disorders,
- degenerative neurological disorders,
- epilepsy,
- severe medical conditions,
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 |
|---|---|---|
| tDCSAlso: HDC Stim device NewronicaStroke rehabilitation performed with the aid of a transcranial electrical stimulation device. | Device | rTMS+tDCS, tDCS+rTMS |
| rTMSAlso: PowerMAG 100 MAG&MoreStroke rehabilitation performed with the aid of a repetitive transcranial magnetic stimulation device. | Device | rTMS+tDCS, tDCS+rTMS |
| ShamAlso: HDC Stim device NewronicaStroke sham stimulation performed with the aid of a transcranial electrical stimulation device. | Device | Sham stimulation |
Primary outcome
Change from the baseline ARAT (measures Grasp, Grip, Pinch, Gross Movement)
Time frame: Baseline; 1 month; 3 months; 6 months; 6 months and 1 week; 7 months; 9 months; 12 months
Action Research Arm Test (ARAT) measures Grasp, Grip, Pinch, Gross Movement. Baseline is 1 week before first treatment; other time frame: 1 week after first treatment; 3 months after first treatment; 6 months follow-up after first treatment; 1 week before second treatment; 1 week after second treatment; 3 months follow-up after second treatment; 6 months follow-up after second treatment.
2 secondary outcomes
P300 (latency)
Time frame: Baseline; 1 month; 6 months and 1 week; 7 months
Cognition (standardized neuropsychological assessment)
Time frame: Baseline; 1 month; 6 months; 6 months and 1 week; 7 months; 12 months
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 Aug 2015.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Federico D'Agata, PhD principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and rTMS in people with Stroke, run by University of Turin, Italy at 1 site in Italy.
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 1 inclusion and 6 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 Aug 2015. 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 Italy. 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 from the baseline ARAT (measures Grasp, Grip, Pinch, Gross Movement) (time frame: Baseline; 1 month; 3 months; 6 months; 6 months and 1 week; 7 months; 9 months; 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2015.