Acute Ischaemic StrokeNCT01207336
Combined tDCS+PNS After Acute Stroke
A study testing combined transcranial direct current stimulation and electrical peripheral nerve stimulation in people with Acute Ischaemic Stroke, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Recent work showed that application of peripheral nerve and cortical stimulation independently can induce 10-15 % improvement in motor performance in patients with chronic stroke. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Acute Ischaemic Stroke
- What is being tested?
- combined transcranial direct current stimulation and electrical peripheral nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to 30 Aug 2012
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first -ever ischemic stroke within 5-30 days a paresis of the arm/hand with NIHSS <15 age 35-85 years
Who cannot join
- Pregnancy psychiatric disease patients with history of alcohol or drug abuse or severe depression patients with a severe language disturbances, particularly of receptive nature patients with increased intracranial pressure or serious cardiac disease patients with contraindication to TMS
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d' Investigation Clinique de Toulouse et Hopitaux de Toulouse ( Purpan)
Toulouse, 31059
About this study
Official title: Effect of Combined Anodal tDCS and Peripheral Nerve Stimulation on Motor Recovery in Acute Stroke
Recent work showed that application of peripheral nerve and cortical stimulation independently can induce 10-15 % improvement in motor performance in patients with chronic stroke.
The purpose of this study was to compare in post-stroke hemiplegic patients the effect on motor recovery of one session of anodal transcranial direct current stimulation to the ipsilesional primary motor cortex (M1) combined with a peripheral radial nerve electrical stimulation (rEPNS) to the paretic hand repeated 5 successive days with the effect of the same peripheral nerve stimulation combined with sham tDCS.
Design: randomized, double-blind, parallel controlled clinical trial. Patients eligible for the study: Acute ischaemic stroke Primary outcome measure: Jebsen Taylor test Secondary outcome measures Nine peg hole test Hand tapping grip and wrist force Cortical excitability of Ipsilesional M1(TMS) Follow-up: 30 days
- Conditions
- Acute Ischaemic Stroke
- Being tested
- combined transcranial direct current stimulation and electrical peripheral nerve stimulation, Combined transcranial placebo cortical stimulation (placebo tDCS)
- Keywords
- stroke, rehabilitation, transcranial direct current stimulation, nerve stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined transcranial direct current stimulation and electrical peripheral nerve stimulationDevice
tDCS: 1,2 mA 13 minutes rEPNS (radial nerve): 5 Hz, 0,7 x MT
Combined transcranial placebo cortical stimulation (placebo tDCS)Device
tDCS: 1,2 mA 13 minutes rEPNS (radial nerve): 5 Hz, 0,7 x MT
| Study group | Role | What they receive |
|---|---|---|
| tDCS + rEPNS | Active comparator | Patients with hemiplegia due to a stroke : application of 5 consecutive sessions of true anodal tDCS applied to the primary motor cortex on the affected side, combined with repetitive peripheral electrical stimulation Receives: Device: combined transcranial direct current stimulation and electrical peripheral nerve stimulation |
| tDCS placebo + rEPNS | Placebo comparator | Patients with hemiplegia due to a stroke : application of 5 consecutive sessions of peripheral electrical stimulation (rEPNS), combined with placebo cortical stimulation (placebo tDCS) Receives: Device: Combined transcranial placebo cortical stimulation (placebo tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jebsen Taylor test
Measured: 5-15-30 days
Secondary outcomes (1)
Grip and wrist force Nine peg hole Cortical excitability ofIpsilesional M1 (TMS)
Measured: 5-15-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startSep 2010
- Primary completion30 Aug 2012
- Study completion30 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute Ischaemic StrokeStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Fondation de l'Avenir
- Responsible party
- Sponsor
- Investigators
- Marion SIMONETTA-MOREAU, MDPhD, Study director, Inserm; Imagerie cerebrale et handicaps neurologiques UMR 825; F-31059 Toulouse, FranceFrançois CHOLLET, MDPhD, Principal investigator, Centre Hospitalier Universitaire de Toulouse; Pole Neurosciences; CHU Purpan, Place du Dr Baylac, F-31059 Toulouse Cedex 9, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207336
- Sponsor's protocol ID
- C09-27
- Other IDs
- 2009-A01153-54
- Status last verified
- Jan 2025
- First submitted
- 21 Sep 2010
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Loubinoux I, Dechaumont-Palacin S, Castel-Lacanal E, De Boissezon X, Marque P, Pariente J, Albucher JF, Berry I, Chollet F. Prognostic value of FMRI in recovery of hand function in subcortical stroke patients. Cereb Cortex. 2007 Dec;17(12):2980-7. doi: 10.1093/cercor/bhm023. Epub 2007 Mar 26.
PubMed 17389628Castel-Lacanal E, Gerdelat-Mas A, Marque P, Loubinoux I, Simonetta-Moreau M. Induction of cortical plastic changes in wrist muscles by paired associative stimulation in healthy subjects and post-stroke patients. Exp Brain Res. 2007 Jun;180(1):113-22. doi: 10.1007/s00221-006-0844-5. Epub 2007 Jan 31.
PubMed 17265041Castel-Lacanal E, Marque P, Tardy J, de Boissezon X, Guiraud V, Chollet F, Loubinoux I, Moreau MS. Induction of cortical plastic changes in wrist muscles by paired associative stimulation in the recovery phase of stroke patients. Neurorehabil Neural Repair. 2009 May;23(4):366-72. doi: 10.1177/1545968308322841. Epub 2008 Dec 5.
PubMed 19060132Conchou F, Loubinoux I, Castel-Lacanal E, Le Tinnier A, Gerdelat-Mas A, Faure-Marie N, Gros H, Thalamas C, Calvas F, Berry I, Chollet F, Simonetta Moreau M. Neural substrates of low-frequency repetitive transcranial magnetic stimulation during movement in healthy subjects and acute stroke patients. A PET study. Hum Brain Mapp. 2009 Aug;30(8):2542-57. doi: 10.1002/hbm.20690.
PubMed 19072894Celnik P, Paik NJ, Vandermeeren Y, Dimyan M, Cohen LG. Effects of combined peripheral nerve stimulation and brain polarization on performance of a motor sequence task after chronic stroke. Stroke. 2009 May;40(5):1764-71. doi: 10.1161/STROKEAHA.108.540500. Epub 2009 Mar 12.
PubMed 19286579Uy J, Ridding MC. Increased cortical excitability induced by transcranial DC and peripheral nerve stimulation. J Neurosci Methods. 2003 Aug 15;127(2):193-7. doi: 10.1016/s0165-0270(03)00142-0.
PubMed 12906948Sattler V, Acket B, Raposo N, Albucher JF, Thalamas C, Loubinoux I, Chollet F, Simonetta-Moreau M. Anodal tDCS Combined With Radial Nerve Stimulation Promotes Hand Motor Recovery in the Acute Phase After Ischemic Stroke. Neurorehabil Neural Repair. 2015 Sep;29(8):743-54. doi: 10.1177/1545968314565465. Epub 2015 Jan 7.
PubMed 25567120Elsner 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Anodal tDCS and Peripheral Nerve Stimulation on Motor Recovery in Acute Stroke
- ClinicalTrials.gov ID
- NCT01207336
- Acronym / sponsor ID
- C09-27
- Conditions
- Acute Ischaemic Stroke
- Keywords
- stroke, rehabilitation, transcranial direct current stimulation, nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Fondation de l'Avenir
- Study start
- Sep 2010 (actual)
- Primary completion
- 30 Aug 2012 (actual)
- Study completion
- 30 Aug 2012 (actual)
- First posted
- 22 Sep 2010 (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.
Recent work showed that application of peripheral nerve and cortical stimulation independently can induce 10-15 % improvement in motor performance in patients with chronic stroke.
The purpose of this study was to compare in post-stroke hemiplegic patients the effect on motor recovery of one session of anodal transcranial direct current stimulation to the ipsilesional primary motor cortex (M1) combined with a peripheral radial nerve electrical stimulation (rEPNS) to the paretic hand repeated 5 successive days with the effect of the same peripheral nerve stimulation combined with sham tDCS.
Design: randomized, double-blind, parallel controlled clinical trial. Patients eligible for the study: Acute ischaemic stroke Primary outcome measure: Jebsen Taylor test Secondary outcome measures Nine peg hole test Hand tapping grip and wrist force Cortical excitability of Ipsilesional M1(TMS) Follow-up: 30 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS + rEPNS | Active comparator | Device: combined transcranial direct current stimulation and electrical peripheral nerve stimulationPatients with hemiplegia due to a stroke : application of 5 consecutive sessions of true anodal tDCS applied to the primary motor cortex on the affected side, combined with repetitive peripheral electrical stimulation |
| tDCS placebo + rEPNS | Placebo comparator | Device: Combined transcranial placebo cortical stimulation (placebo tDCS)Patients with hemiplegia due to a stroke : application of 5 consecutive sessions of peripheral electrical stimulation (rEPNS), combined with placebo cortical stimulation (placebo tDCS) |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- first -ever ischemic stroke within 5-30 days a paresis of the arm/hand with NIHSS <15 age 35-85 years
Key exclusion criteria (1 listed)
- Pregnancy psychiatric disease patients with history of alcohol or drug abuse or severe depression patients with a severe language disturbances, particularly of receptive nature patients with increased intracranial pressure or serious cardiac disease patients with contraindication to TMS
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 |
|---|---|---|
| combined transcranial direct current stimulation and electrical peripheral nerve stimulationtDCS: 1,2 mA 13 minutes rEPNS (radial nerve): 5 Hz, 0,7 x MT | Device | tDCS + rEPNS |
| Combined transcranial placebo cortical stimulation (placebo tDCS)tDCS: 1,2 mA 13 minutes rEPNS (radial nerve): 5 Hz, 0,7 x MT | Device | tDCS placebo + rEPNS |
Primary outcome
Jebsen Taylor test
Time frame: 5-15-30 days
1 secondary outcome
Grip and wrist force Nine peg hole Cortical excitability ofIpsilesional M1 (TMS)
Time frame: 5-15-30 days
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 20 Jul 2026.
- Background: PubMed 17389628Loubinoux I, Dechaumont-Palacin S, Castel-Lacanal E, De Boissezon X, Marque P, Pariente J, Albucher JF, Berry I, Chollet F. Prognostic value of FMRI in recovery of hand function in subcortical stroke patients. Cereb Cortex. 2007 Dec;17(12):2980-7. doi: 10.1093/cercor/bhm023. Epub 2007 Mar 26.
- Background: PubMed 17265041Castel-Lacanal E, Gerdelat-Mas A, Marque P, Loubinoux I, Simonetta-Moreau M. Induction of cortical plastic changes in wrist muscles by paired associative stimulation in healthy subjects and post-stroke patients. Exp Brain Res. 2007 Jun;180(1):113-22. doi: 10.1007/s00221-006-0844-5. Epub 2007 Jan 31.
- Background: PubMed 19060132Castel-Lacanal E, Marque P, Tardy J, de Boissezon X, Guiraud V, Chollet F, Loubinoux I, Moreau MS. Induction of cortical plastic changes in wrist muscles by paired associative stimulation in the recovery phase of stroke patients. Neurorehabil Neural Repair. 2009 May;23(4):366-72. doi: 10.1177/1545968308322841. Epub 2008 Dec 5.
- Background: PubMed 19072894Conchou F, Loubinoux I, Castel-Lacanal E, Le Tinnier A, Gerdelat-Mas A, Faure-Marie N, Gros H, Thalamas C, Calvas F, Berry I, Chollet F, Simonetta Moreau M. Neural substrates of low-frequency repetitive transcranial magnetic stimulation during movement in healthy subjects and acute stroke patients. A PET study. Hum Brain Mapp. 2009 Aug;30(8):2542-57. doi: 10.1002/hbm.20690.
- Background: PubMed 19286579Celnik P, Paik NJ, Vandermeeren Y, Dimyan M, Cohen LG. Effects of combined peripheral nerve stimulation and brain polarization on performance of a motor sequence task after chronic stroke. Stroke. 2009 May;40(5):1764-71. doi: 10.1161/STROKEAHA.108.540500. Epub 2009 Mar 12.
- Background: PubMed 12906948Uy J, Ridding MC. Increased cortical excitability induced by transcranial DC and peripheral nerve stimulation. J Neurosci Methods. 2003 Aug 15;127(2):193-7. doi: 10.1016/s0165-0270(03)00142-0.
- Results publication: PubMed 25567120Sattler V, Acket B, Raposo N, Albucher JF, Thalamas C, Loubinoux I, Chollet F, Simonetta-Moreau M. Anodal tDCS Combined With Radial Nerve Stimulation Promotes Hand Motor Recovery in the Acute Phase After Ischemic Stroke. Neurorehabil Neural Repair. 2015 Sep;29(8):743-54. doi: 10.1177/1545968314565465. Epub 2015 Jan 7.
- 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.
Marion SIMONETTA-MOREAU, MDPhD study director
Inserm; Imagerie cerebrale et handicaps neurologiques UMR 825; F-31059 Toulouse, France
François CHOLLET, MDPhD principal investigator
Centre Hospitalier Universitaire de Toulouse; Pole Neurosciences; CHU Purpan, Place du Dr Baylac, F-31059 Toulouse Cedex 9, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined transcranial direct current stimulation and electrical peripheral nerve stimulation in people with Acute Ischaemic Stroke, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 1 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 20 Jul 2026. 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 France. 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?
Jebsen Taylor test (time frame: 5-15-30 days). 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 NCT01207336, which also lists 8 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 20 Jul 2026.