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StrokeT-STARNCT06842095

Investigating the Effects of Transcranial Stimulation to Advance Stroke Rehabilitation

A study testing Transcranial Alternating Current Stimulation (beta-tACS) in people with Stroke and Upper Limb Function, run by University of Oxford at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Non-invasive brain stimulation (NIBS) has the potential to boost rehabilitation after stroke by creating a 'pro-plastic' environment, where the brain is more adaptable in response to movement (motor) training. However, responses to classical NIBS protocols are highly variable. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Upper Limb Function
What is being tested?
Transcranial Alternating Current Stimulation (beta-tACS)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited Kingdom
Study dates
1 Feb 2025to 28 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Participant is willing and able to give informed consent for participation in the study.
  • Aged 18 years or above.
  • Clinical diagnosis of stroke affecting the upper limb, with sufficient ability to perform the upper limb reaching task.
  • At least 3 months post-stroke and discharged from inpatient care.

Who cannot join

  • Inability to follow task instructions.
  • Other neurological condition affecting movement (e.g. Parkinson's Disease, Multiple Sclerosis).
  • Standard contraindications to non-invasive brain stimulation (TMS, tACS). including (but not limited to) the presence of intracranial metallic or magnetic hardware, seizures, pregnancy, and the presence of a pacemaker or other stimulators/implants.
  • Insufficient verbal and written English to comprehend the study and provide informed consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site, 1 recruiting
  • Oxford Centre for Functional MRI of the Brain (FMRIB)

    Oxford, OX3 9DU

    Stuart Clare, PhD, +44 1865 611451, stuart.clare@ndcn.ox.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: Investigating the Effects of Beta Transcranial Stimulation to Advance Stroke Rehabilitation

Non-invasive brain stimulation (NIBS) has the potential to boost rehabilitation after stroke by creating a 'pro-plastic' environment, where the brain is more adaptable in response to movement (motor) training. However, responses to classical NIBS protocols are highly variable.

Movement-related changes in specific brain rhythms have previously been shown to be related to recovery of hand/arm function after a stroke. The investigators propose to use NIBS to target movement-related activity in the beta band (13-30Hz) within the motor cortical regions of the brain. The investigators will use a type of NIBS called transcranial alternating current stimulation (tACS), which uses a sinusoidally-varying electrical current where the stimulation frequency is determined to be relevant to the underlying brain rhythms of interest, and the stimulation timed to coincide with specific phases of the hand/arm movement.

The primary aim is to investigate whether beta-tACS improves upper limb movement in stroke survivors.

Read the detailed description

Stroke is a leading cause of death and long-term disability worldwide. More than 70% of stroke survivors experience motor impairments, often resulting in difficulties in daily activities, such as walking, reaching and grasping objects. Regaining upper-limb motor function is key to quality of life and for reducing the high annual costs due to stroke.

Research indicates that upper-limb motor function recovery depends on the plasticity of neural circuits controlling movement. Beta activity (β, ~13-30 Hz) in the sensorimotor cortex has been associated with brain plasticity and has been proposed to play a pivotal role in human movement and movement disorders. This activity attenuates during movement execution, known as event-related desynchronization (β-ERD), and temporarily increases after the end of movement, known as event-related synchronization (β-ERS).

β-ERD and β-ERS are reliably observed during active and passive movement, movement imagination and movement observation. Changes in movement-related β-ERD and β-ERS have been linked to motor learning, and motor dysfunction in neurological conditions, such as stroke. Studies have shown that stroke survivors with upper limb impairments exhibit significantly lower beta activity compared to healthy individuals, and recovery-related improvements in motor function are accompanied by increases in both sensorimotor β-ERD and β-ERS.

Therefore, modulation of movement-related beta activity (i.e., β-ERD and β-ERS) holds great promise for promoting motor function after stroke. Non-invasive brain stimulation (NIBS) can be applied during movements to increase plasticity and enhance motor learning and function. However, prior studies have delivered NIBS using a relatively broad approach; modulating general cortical excitability rather than enhancing specific endogenous oscillations in the brain. Transcranial alternating current stimulation (tACS) is a safe and well-tolerated type of NIBS which provides an option for modulating specific frequencies of brain oscillations by delivering a low-intensity sinusoidal electrical current to the brain at a specific frequency.

Therefore, this study will deliver beta-tACS to the ipsilesional motor cortex (M1) aiming to modulate sensorimotor beta activity during upper limb movement in stroke survivors. This study will investigate whether functionally timed beta-tACS has the potential to enhance motor recovery, by assessing whether stimulation delivered at the end of the movement improves upper limb movement (accuracy, smoothness and hand function) and increases the modulation of beta activity. Additionally, the investigators will evaluate whether the effectiveness of the stimulation relates to baseline neuroimaging and neurophysiological measures. Identifying correlates of intervention responsiveness will help future studies to target patients who are most likely to benefit.

Being tested
Transcranial Alternating Current Stimulation (beta-tACS), Transcranial Alternating Current Stimulation (sham)
Keywords
Non-Invasive Brain Stimulation, Stroke, Upper Limb, Electroencephalography, Transcranial Alternating Current Stimulation, Beta Oscillations
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Alternating Current Stimulation (beta-tACS)Other

    Also called Non Invasive Brain Stimulation, beta tACS

    The study intervention is transcranial alternating current stimulation (tACS).

    The electrode montage will include one electrode positioned on the scalp over the left or right motor cortex (either C3 or C4 using the international 10-20 EEG system), depending on the location of the stroke, and a second electrode over posterior area (Pz). A low intensity of stimulation (max. 4 mA peak to peak amplitude) will be used for up to 30 minutes in total (delivered in short bouts of up to 5 seconds based on the timing of movement of the upper limb).

  • Transcranial Alternating Current Stimulation (sham)Other

    Also called tACS (sham)

    The comparator is sham stimulation. Stimulation is delivered for a very short duration or timed in such a way relative to movement to mimic the scalp sensations of the active stimulation without delivering stimulation that would be anticipated to impact relevant brain activity rhythms.

Study groups in NCT06842095
Study groupRoleWhat they receive
Active Stimulation (beta-tACS)ExperimentalParticipants will receive one session of active stimulation (beta-tACS) to the ipsilesional hemisphere. The electrode montage will include one electrode positioned on the scalp over the left or right motor cortex (either C3 or C4 using the international 10-20 EEG system), depending on the location of the stroke, and a second electrode over posterior area (Pz). A low intensity of stimulation (max. 4 mA peak to peak amplitude) will be used for up to 30 minutes in total (delivered in short bouts of up to 5 seconds based on the timing of movement of the upper limb).
Receives: Other: Transcranial Alternating Current Stimulation (beta-tACS)
Sham Stimulation (tACS)Sham comparatorParticipants will receive one session of sham stimulation. The electrode placement will be the same as for the experimental condition, but duration or timing of stimulation will be insufficient to induce intended brain rhythm changes.
Receives: Other: Transcranial Alternating Current Stimulation (sham)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reaching Performance

    Performance on the reaching task, assessed using a motion sensor as the error (deviation from the ideal path) in cubic centimeters. Higher numbers indicate worse error/reaching performance.

    Measured: From the first stimulation session to the completion of the third and final session, an average of 1 month

Secondary outcomes (2)
  1. Movement-related Brain Rhythms

    Movement-related beta activity measured using electroencephalography (EEG), as power in decibels. Higher values indicate stronger (better) movement-related beta activity.

    Measured: From the first stimulation session to the completion of the third and final session, an average of 1 month

  2. Hand Function

    Change in hand function measured with the Box and Blocks Test from pre-stimulation to post-stimulation. Box and blocks test performance is measured as the number of blocks moved with the affected hand in 1 minute, higher numbers indicate better hand function.

    Measured: From the first stimulation session to the completion of the third and final session, an average of 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2025
  2. Study start1 Feb 2025
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06842095
Sponsor's protocol ID
PID17878
Acronym
T-STAR
Status last verified
Jul 2024
First submitted
23 Oct 2024
Last updated
7 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be available on reasonable request to the Chief Investigator, Dr Fleming or Dr Zich.

Publications

  • Wischnewski M, Schutter DJLG, Nitsche MA. Effects of beta-tACS on corticospinal excitability: A meta-analysis. Brain Stimul. 2019 Nov-Dec;12(6):1381-1389. doi: 10.1016/j.brs.2019.07.023. Epub 2019 Jul 28.

    PubMed 31405789
  • Toledo DR, Manzano GM, Barela JA, Kohn AF. Cortical correlates of response time slowing in older adults: ERP and ERD/ERS analyses during passive ankle movement. Clin Neurophysiol. 2016 Jan;127(1):655-663. doi: 10.1016/j.clinph.2015.05.003. Epub 2015 May 9.

    PubMed 26024982
  • Tang CW, Hsiao FJ, Lee PL, Tsai YA, Hsu YF, Chen WT, Lin YY, Stagg CJ, Lee IH. beta-Oscillations Reflect Recovery of the Paretic Upper Limb in Subacute Stroke. Neurorehabil Neural Repair. 2020 May;34(5):450-462. doi: 10.1177/1545968320913502. Epub 2020 Apr 23.

    PubMed 32321366
  • Stancak A Jr, Pfurtscheller G. Desynchronization and recovery of beta rhythms during brisk and slow self-paced finger movements in man. Neurosci Lett. 1995 Aug 18;196(1-2):21-4. doi: 10.1016/0304-3940(95)11827-j.

    PubMed 7501247
  • Stagg CJ, Bachtiar V, Johansen-Berg H. The role of GABA in human motor learning. Curr Biol. 2011 Mar 22;21(6):480-4. doi: 10.1016/j.cub.2011.01.069. Epub 2011 Mar 3.

    PubMed 21376596
  • Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.

    PubMed 33243615
  • Pogosyan A, Gaynor LD, Eusebio A, Brown P. Boosting cortical activity at Beta-band frequencies slows movement in humans. Curr Biol. 2009 Oct 13;19(19):1637-41. doi: 10.1016/j.cub.2009.07.074. Epub 2009 Oct 1.

    PubMed 19800236
  • Pfurtscheller G, Neuper C, Brunner C, da Silva FL. Beta rebound after different types of motor imagery in man. Neurosci Lett. 2005 Apr 22;378(3):156-9. doi: 10.1016/j.neulet.2004.12.034. Epub 2005 Jan 8.

    PubMed 15781150
  • Pfurtscheller G, Berghold A. Patterns of cortical activation during planning of voluntary movement. Electroencephalogr Clin Neurophysiol. 1989 Mar;72(3):250-8. doi: 10.1016/0013-4694(89)90250-2.

    PubMed 2465128
  • Peter J, Ferraioli F, Mathew D, George S, Chan C, Alalade T, Salcedo SA, Saed S, Tatti E, Quartarone A, Ghilardi MF. Movement-related beta ERD and ERS abnormalities in neuropsychiatric disorders. Front Neurosci. 2022 Nov 23;16:1045715. doi: 10.3389/fnins.2022.1045715. eCollection 2022.

    PubMed 36507340
  • Owolabi MO, Thrift AG, Mahal A, Ishida M, Martins S, Johnson WD, Pandian J, Abd-Allah F, Yaria J, Phan HT, Roth G, Gall SL, Beare R, Phan TG, Mikulik R, Akinyemi RO, Norrving B, Brainin M, Feigin VL; Stroke Experts Collaboration Group. Primary stroke prevention worldwide: translating evidence into action. Lancet Public Health. 2022 Jan;7(1):e74-e85. doi: 10.1016/S2468-2667(21)00230-9. Epub 2021 Oct 29.

    PubMed 34756176
  • Neuper C, Wortz M, Pfurtscheller G. ERD/ERS patterns reflecting sensorimotor activation and deactivation. Prog Brain Res. 2006;159:211-22. doi: 10.1016/S0079-6123(06)59014-4.

    PubMed 17071233
  • Muller-Putz GR, Zimmermann D, Graimann B, Nestinger K, Korisek G, Pfurtscheller G. Event-related beta EEG-changes during passive and attempted foot movements in paraplegic patients. Brain Res. 2007 Mar 16;1137(1):84-91. doi: 10.1016/j.brainres.2006.12.052. Epub 2006 Dec 22.

    PubMed 17229403
  • Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.

    PubMed 3160243
  • Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available.

    PubMed 7333761

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Alternating Current Stimulation (beta-tACS) in people with Stroke and Upper Limb Function, run by University of Oxford at 1 site in United Kingdom.

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 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: looking for participants now, as of the sponsor's last update on 7 Mar 2025. 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 Kingdom. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Melanie Fleming, PhD (+44 1865 611461, melanie.fleming@ndcn.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reaching Performance (time frame: From the first stimulation session to the completion of the third and final session, an average of 1 month). 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 NCT06842095, which also lists 29 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 7 Mar 2025.

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