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StrokeNCT03122821

Trans Cranial Brain Stimulation for Stroke Rehabilitation

A study testing Real Transcranial direct stimulation+Mental Imagery in people with Stroke, run by Majmaah University at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Noninvasive brain stimulation (NIBS) refers to a group of modalities that are used to induce electric currents to and within the brain for diagnostic or therapeutic purposes. Two major types of NIBS techniques are currently in use on humans for clinical and research applications: Transcranial Magnetic Stimulation… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke
What is being tested?
Real Transcranial direct stimulation+Mental Imagery
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteIndia
Study dates
12 Apr 2017to 1 Sep 2022
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Having stroke past 6 months.

Who cannot join

  • Subarachnoid hemorrhage
  • Prior to stroke resulting in aphasia
  • Brain surgery in the past
  • Epileptic activity in the past 12 months
  • Premorbid (suspected) dementia
  • Premorbid psychiatric disease affecting communication (for example, personality disorder)
Show all 9Show fewer
  • Excessive use of alcohol or drugs
  • Presence of a cardiac pacemaker
  • Metal implants

Trial locations and contacts

1 site in 1 country.

India1 site
  • NIIMS University hospital

    Jaipur, Rajasthan, 303121

Other trials in India

About this study

Official title: Effect of Transcranial Stimulation Augmented With Mental Imagery in Upper Limb Stroke Rehabilitation: A Randomized Controlled Trial

Noninvasive brain stimulation (NIBS) refers to a group of modalities that are used to induce electric currents to and within the brain for diagnostic or therapeutic purposes. Two major types of NIBS techniques are currently in use on humans for clinical and research applications: Transcranial Magnetic Stimulation (TMS) and Transcranial Current Stimulation (tCS). Moreover, the studies evaluating the clinical benefit of mental practice in stroke so far are mostly small feasibility studies, while the few randomized controlled trials reported had relatively small sample sizes. As such, the evidence for mental practice in the treatment of movement disorders following stroke, and other neurological conditions, remains somewhat anecdotal. Purpose of our research is to show the effect of combining brain stimulation and mental imagery on functional recovery of upper limb in stroke.

Read the detailed description

TITLE Effect of Transcranial Stimulation augmented with Mental Imagery in Upper Limb Stroke Rehabilitation: A Randomized Controlled Trial

Mr. Faizan Zaffar Kashoo

Department of Physical Therapy and Health rehabilitation, College of Applied Medical sciences. Majmaah University. KSA

INTRODUCTION

Noninvasive brain stimulation (NIBS) refers to a group of modalities that are used to induce electric currents to and within the brain for diagnostic or therapeutic purposes [1-4]. A growing body of evidence suggests that NIBS techniques may have a promising role in the diagnosis, monitoring, and treatment of a variety of neurological and psychiatric conditions [5-9]. The therapeutic potential of NIBS stems from the capacity to evoke immediate and sustained modulation of neural network activity through alterations in neuronal excitation. The induced neuromodulation can be either excitatory or inhibitory, depending on the polarity, frequency, and duration of the stimulation [2, 10]. Moreover, the ability to induce directional modulation further enhances the therapeutic possibilities of NIBS, as the necessary direction of the brain excitability for recovery varies with different disease conditions [10, 11].

Two major types of NIBS techniques are currently in use on humans for clinical and research applications: Transcranial Magnetic Stimulation (TMS) and Transcranial Current Stimulation (tCS) [12]. TMS uses a varying magnetic field to induce weak electric currents in the brain. It can be delivered as a single pulse or as a train of pulses. Single-pulse TMS is typically used to study brain physiology and plasticity [3, 13-16], whereas repetitive-pulse TMS (rTMS) is commonly used to elicit neuromodulation and neuroplasticity, and can result in prolonged excitability changes that outlast the stimulation period [6, 15]. Typically, the direction of neuromodulation is driven by the frequency at which the stimulation is performed, such that high-frequency rTMS increases cortical excitability and low-frequency rTMS decreases cortical excitability [17]. However, theta burst stimulation (a variation of high frequency rTMS) can induce either depression or facilitation of cortical excitability, depending on burst-train duration, such that intermittent theta burst stimulation increases cortical excitability and continuous theta burst stimulation decreases cortical excitability [18].

tCS refers to the application of direct or alternating current on a specific region of the brain, transmitted via electrodes attached to the scalp. A wide range of tCS modalities exists, but only a few have been well-studied. Transcranial direct current stimulation (tDCS), (or "Transcranial Micropolarization"), is the most commonly used type of tCS [2, 19-25]. It employs a battery-driven stimulator to deliver weak direct currents (0.5-2.0 mA) through contact electrodes over the scalp. The current flow modulates neuronal excitability by altering the resting membrane potential of the neurons and produces aftereffects (i.e., prolonged changes in neuronal excitability) that are thought to be driven by Glutamatergic and GABAergic synapsic plasticity [26]. tDCS can be used to elicit an excitatory (anodal) or inhibitory (cathodal) effect, depending on the polarity of stimulation. Specifically, anodal stimulation has a depolarizing effect, which increases neuronal excitability; whereas, cathodal stimulation has a hyperpolarizing effect, which decreases neuronal excitability [1, 19, 27, 28].

Much interest has been raised by the potential of mental practice of motor tasks, also called 'motor imagery', as a neuro-rehabilitation technique to enhance motor recovery following stroke 29-31. The appeal of motor imagery as a potentially effective neuro-rehabilitation technique is popular, which is reflected in multiple reviews of relatively few reported clinical evaluations. Moreover, the studies evaluating the clinical benefit of mental practice in stroke so far are mostly small feasibility studies, while the few randomized controlled trials reported had relatively small sample sizes. As such, the evidence for mental practice in the treatment of movement disorders following stroke, and other neurological conditions, remains somewhat anecdotal. Purpose of our research is to show the effect of combined effect of brain stimulation and mental imagery.

RESEARCH HYPOTHESIS

There will be a significant difference between control and experimental groups.

NULL HYPOTHESIS

There will be no significant difference between control and experimental groups.

STUDY DESIGN (TYPE OF STUDY)

Doubled blinded randomized controlled trial.

STUDY POPULATION AND SAMPLING

Chronic stroke and random sampling

DATA COLLECTION METHODS AND INSTRUMENTS

Procedure:

The electrodes will be placed at the premotor cortex over the scalp corresponding to the topographical representation of upper limb on the contralateral cerebral hemisphere.

Transcranial direct stimulation for 30 minutes, 5 days a week for 2 weeks Mental imagery as visual imagery shown to the patient with the help of videotape.

Instrumentation:

Fugl Meyers Scale ARAT

Activities:

exercises: 1. stacking blocks; 2. flipping scrapbook pages; 3. nine-hole pegboard; 4. grabbing saucepan and pouring water into a cup; and 5. opening hand to grasp and pick up cup.

DATA ANALYSIS METHODS

An appropriate quantitative statistical method will be used

STUDY PERIOD

2 year

Conditions
Stroke
Being tested
Real Transcranial direct stimulation+Mental Imagery, Sham Transcranial Direct Stimulation +Mental Imagery
Medical subject headings
Stroke

What participants receive

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

  • Real Transcranial direct stimulation+Mental ImageryOther

    The subject will be practicing mental imagery along with mental imagery. A video of the task will be played in front of the patient and the subject will be asked to perform the mental practice of the activity.The video will be played thrice.The electrodes will be placed at the premotor cortex over the scalp corresponding to the topographical representation of upper limb on the contralateral cerebral hemisphere.Transcranial direct current stimulation (tDCS), (or "Transcranial Micropolarization"), is the most commonly used type of tCS [2, 19-25]. It employs a battery-driven stimulator to deliver weak direct currents (1.5 mA) through contact electrodes over the scalp. The current flow modulates neuronal excitability by altering the resting membrane potential of the neurons and produces aftereffects.Transcranial magnetic stimulation for 30 minutes, 5 days a week for 2 weeks.Transcranial direct stimulation for 30 minutes, 5 days a week for 2 weeks

  • Sham Transcranial Direct Stimulation +Mental ImageryOther

    The electrodes will be placed at the premotor cortex over the scalp corresponding to the topographical representation of upper limb on the contralateral cerebral hemisphere.Transcranial direct current stimulation (tDCS), (or "Transcranial Micropolarization"), is the most commonly used type of tCS [2, 19-25]. It employs a battery-driven stimulator to deliver weak direct currents (1.5 mA) through contact electrodes over the scalp. The current flow modulates neuronal excitability by altering the resting membrane potential of the neurons and produces aftereffects.Transcranial magnetic stimulation for 30 minutes, 5 days a week for 2 weeks.Transcranial direct stimulation for 30 minutes, 5 days a week for 2 weeks

Study groups in NCT03122821
Study groupRoleWhat they receive
Group 1ExperimentalReal Trans-cranial direct stimulation + Mental Imagery
Receives: Other: Real Transcranial direct stimulation+Mental Imagery
Group 2Active comparatorSham Trans-cranial direct stimulation + Mental imagery
Receives: Other: Sham Transcranial Direct Stimulation +Mental Imagery

What is being measured

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

  1. Fugl Meyers scale for upper limb

    Subjects will be rated on impairment of upper limb. The maximum score of 66 for the upper limb, higher scores imply better outcomes.

    Measured: 15 minutes

Secondary outcomes (1)
  1. Action research Arm Test

    Subjects will be rated on performance and functional activity. The maximum score of 56 for the upper limb, higher scores imply better outcomes.

    Measured: 15 minutes

Timeline

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

  1. First posted21 Apr 2017
  2. Study start12 Apr 2017
  3. Primary completion15 Aug 2022
  4. Study completion1 Sep 2022

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
Parallel groups
Model description
Transcranial magnetic stimulation
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03122821
Sponsor's protocol ID
MajmaahU
Status last verified
Oct 2022
First submitted
13 Apr 2017
Last updated
6 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guleyupoglu B, Schestatsky P, Edwards D, Fregni F, Bikson M. Classification of methods in transcranial electrical stimulation (tES) and evolving strategy from historical approaches to contemporary innovations. J Neurosci Methods. 2013 Oct 15;219(2):297-311. doi: 10.1016/j.jneumeth.2013.07.016. Epub 2013 Aug 14.

    PubMed 23954780
  • Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.

    PubMed 10990547
  • Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.

    PubMed 19833552
  • Kobayashi M, Pascual-Leone A. Transcranial magnetic stimulation in neurology. Lancet Neurol. 2003 Mar;2(3):145-56. doi: 10.1016/s1474-4422(03)00321-1.

    PubMed 12849236
  • Eldaief MC, Press DZ, Pascual-Leone A. Transcranial magnetic stimulation in neurology: A review of established and prospective applications. Neurol Clin Pract. 2013 Dec;3(6):519-526. doi: 10.1212/01.CPJ.0000436213.11132.8e.

    PubMed 24353923
  • Paulus W, Peterchev AV, Ridding M. Transcranial electric and magnetic stimulation: technique and paradigms. Handb Clin Neurol. 2013;116:329-42. doi: 10.1016/B978-0-444-53497-2.00027-9.

    PubMed 24112906
  • Webster BR, Celnik PA, Cohen LG. Noninvasive brain stimulation in stroke rehabilitation. NeuroRx. 2006 Oct;3(4):474-81. doi: 10.1016/j.nurx.2006.07.008.

    PubMed 17012061
  • Radhu N, de Jesus DR, Ravindran LN, Zanjani A, Fitzgerald PB, Daskalakis ZJ. A meta-analysis of cortical inhibition and excitability using transcranial magnetic stimulation in psychiatric disorders. Clin Neurophysiol. 2013 Jul;124(7):1309-20. doi: 10.1016/j.clinph.2013.01.014. Epub 2013 Feb 26.

    PubMed 23485366
  • Edwards MJ, Talelli P, Rothwell JC. Clinical applications of transcranial magnetic stimulation in patients with movement disorders. Lancet Neurol. 2008 Sep;7(9):827-40. doi: 10.1016/S1474-4422(08)70190-X.

    PubMed 18703005
  • Nitsche MA, Paulus W. Noninvasive brain stimulation protocols in the treatment of epilepsy: current state and perspectives. Neurotherapeutics. 2009 Apr;6(2):244-50. doi: 10.1016/j.nurt.2009.01.003.

    PubMed 19332316
  • Boggio PS, Nunes A, Rigonatti SP, Nitsche MA, Pascual-Leone A, Fregni F. Repeated sessions of noninvasive brain DC stimulation is associated with motor function improvement in stroke patients. Restor Neurol Neurosci. 2007;25(2):123-9.

    PubMed 17726271
  • Davis NJ, van Koningsbruggen MG. "Non-invasive" brain stimulation is not non-invasive. Front Syst Neurosci. 2013 Dec 23;7:76. doi: 10.3389/fnsys.2013.00076. eCollection 2013. No abstract available.

    PubMed 24391554
  • Krishnan C, Dhaher Y. Corticospinal responses of quadriceps are abnormally coupled with hip adductors in chronic stroke survivors. Exp Neurol. 2012 Jan;233(1):400-7. doi: 10.1016/j.expneurol.2011.11.007. Epub 2011 Nov 15.

    PubMed 22116042
  • Krishnan C, Ranganathan R, Kantak SS, Dhaher YY, Rymer WZ. Active robotic training improves locomotor function in a stroke survivor. J Neuroeng Rehabil. 2012 Aug 20;9:57. doi: 10.1186/1743-0003-9-57.

    PubMed 22906099
  • Pascual-Leone A, Tormos JM, Keenan J, Tarazona F, Canete C, Catala MD. Study and modulation of human cortical excitability with transcranial magnetic stimulation. J Clin Neurophysiol. 1998 Jul;15(4):333-43. doi: 10.1097/00004691-199807000-00005.

    PubMed 9736467

Questions about this trial

What is this clinical trial studying?

A study testing Real Transcranial direct stimulation+Mental Imagery in people with Stroke, run by Majmaah University at 1 site in India.

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 9 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 6 Oct 2022. 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 India. 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.

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?

Fugl Meyers scale for upper limb (time frame: 15 minutes). 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 NCT03122821, which also lists 31 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 6 Oct 2022.

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