Investigating the Effects of Transcranial Stimulation to Advance Stroke Rehabilitation
NCT ID: NCT06842095
Last Updated: 2025-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2025-02-01
2027-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transcranial Stimulation and Motor Training in Stroke Rehabilitation
NCT01414582
Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery
NCT00792428
Brain Stimulation-aided Stroke Rehabilitation: Neural Mechanisms of Recovery
NCT01539096
Influence of Theta Burst Stimulation and Carbidopa-Levodopa on Motor Performance in Stroke Patients
NCT00366184
Bifocal Transcranial Alternating Current Stimulation Targeting the Frontoparietal Network in Stroke Patients
NCT06809959
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active Stimulation (beta-tACS)
Participants 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).
Transcranial Alternating Current 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).
Sham Stimulation (tACS)
Participants 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.
Transcranial Alternating Current Stimulation (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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Transcranial Alternating Current 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)
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Oxford
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Charlotte J Stagg, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Catharina Zich, PhD
Role: STUDY_DIRECTOR
University of Oxford
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oxford Centre for Functional MRI of the Brain (FMRIB)
Oxford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Liepert J, Miltner WH, Bauder H, Sommer M, Dettmers C, Taub E, Weiller C. Motor cortex plasticity during constraint-induced movement therapy in stroke patients. Neurosci Lett. 1998 Jun 26;250(1):5-8. doi: 10.1016/s0304-3940(98)00386-3.
Liepert J, Bauder H, Wolfgang HR, Miltner WH, Taub E, Weiller C. Treatment-induced cortical reorganization after stroke in humans. Stroke. 2000 Jun;31(6):1210-6. doi: 10.1161/01.str.31.6.1210.
Lawrence ES, Coshall C, Dundas R, Stewart J, Rudd AG, Howard R, Wolfe CD. Estimates of the prevalence of acute stroke impairments and disability in a multiethnic population. Stroke. 2001 Jun;32(6):1279-84. doi: 10.1161/01.str.32.6.1279.
Kulasingham JP, Brodbeck C, Khan S, Marsh EB, Simon JZ. Bilaterally Reduced Rolandic Beta Band Activity in Minor Stroke Patients. Front Neurol. 2022 Mar 28;13:819603. doi: 10.3389/fneur.2022.819603. eCollection 2022.
Koganemaru S, Mima T, Thabit MN, Ikkaku T, Shimada K, Kanematsu M, Takahashi K, Fawi G, Takahashi R, Fukuyama H, Domen K. Recovery of upper-limb function due to enhanced use-dependent plasticity in chronic stroke patients. Brain. 2010 Nov;133(11):3373-84. doi: 10.1093/brain/awq193. Epub 2010 Aug 5.
Kilavik BE, Zaepffel M, Brovelli A, MacKay WA, Riehle A. The ups and downs of beta oscillations in sensorimotor cortex. Exp Neurol. 2013 Jul;245:15-26. doi: 10.1016/j.expneurol.2012.09.014. Epub 2012 Sep 27.
Joundi RA, Jenkinson N, Brittain JS, Aziz TZ, Brown P. Driving oscillatory activity in the human cortex enhances motor performance. Curr Biol. 2012 Mar 6;22(5):403-7. doi: 10.1016/j.cub.2012.01.024. Epub 2012 Feb 2.
Herrmann CS, Rach S, Neuling T, Struber D. Transcranial alternating current stimulation: a review of the underlying mechanisms and modulation of cognitive processes. Front Hum Neurosci. 2013 Jun 14;7:279. doi: 10.3389/fnhum.2013.00279. eCollection 2013.
Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
Duncan PW, Bode RK, Min Lai S, Perera S; Glycine Antagonist in Neuroprotection Americans Investigators. Rasch analysis of a new stroke-specific outcome scale: the Stroke Impact Scale. Arch Phys Med Rehabil. 2003 Jul;84(7):950-63. doi: 10.1016/s0003-9993(03)00035-2.
Demeyere N, Riddoch MJ, Slavkova ED, Bickerton WL, Humphreys GW. The Oxford Cognitive Screen (OCS): validation of a stroke-specific short cognitive screening tool. Psychol Assess. 2015 Sep;27(3):883-94. doi: 10.1037/pas0000082. Epub 2015 Mar 2.
Chalard A, Amarantini D, Tisseyre J, Marque P, Gasq D. Spastic co-contraction is directly associated with altered cortical beta oscillations after stroke. Clin Neurophysiol. 2020 Jun;131(6):1345-1353. doi: 10.1016/j.clinph.2020.02.023. Epub 2020 Mar 19.
Bachtiar V, Near J, Johansen-Berg H, Stagg CJ. Modulation of GABA and resting state functional connectivity by transcranial direct current stimulation. Elife. 2015 Sep 18;4:e08789. doi: 10.7554/eLife.08789.
Bachtiar V, Johnstone A, Berrington A, Lemke C, Johansen-Berg H, Emir U, Stagg CJ. Modulating Regional Motor Cortical Excitability with Noninvasive Brain Stimulation Results in Neurochemical Changes in Bilateral Motor Cortices. J Neurosci. 2018 Aug 15;38(33):7327-7336. doi: 10.1523/JNEUROSCI.2853-17.2018. Epub 2018 Jul 20.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PID17878
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.