StrokeNCT04646577
The Effect of tDCS Combined With Functional Task Training on Motor Recovery in Stroke Patients
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) and Transcranial Direct Current Stimulation (tDCS in people with Stroke and Stroke, Acute, run by King Fahad Specialist Hospital Dammam.
Trial summary
We propose to enhance the effects of brain plasticity using a powerful noninvasive technique for brain modulation consisting of navigated transcranial magnetic stimulation (TMS) priming with transcranial direct current stimulation (tDCS) in combination with motor-training-like constraint-induced movement therapy… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Stroke, Acute, Motor Function
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS) and Transcranial Direct Current Stimulation (tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 30 May 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-90
- first-time clinical ischemic or hemorrhagic cerebrovascular accident as noted in the radiological (or physician's) report;
- the ability to extend =20° at the wrist and 10° at the metacarpophalangeal and interphalangeal joints of all digits;
- participants must demonstrate adequate balance while wearing the restraint;
- the ability to stand from a sitting position and the ability to stand for at least 2 minutes with or without upper extremity support;
- weakness, defined as score of 15-55 (out of 66) on arm motor Fugl-Meyer (FM) scale; and
- stroke onset more then 6 months prior to study enrollment.
Who cannot join
- significant pre-stroke disability;
- where applicable (a history of depression before the stroke);
- any substantial decrease in alertness, language reception, or attention that might interfere with understanding the instructions for the motor testing;
- excessive pain in any joint of the paretic extremity;
- contraindications to single-pulse TMS (TMS will be used to measure cortical excitability) such as metal head implants;
- advanced liver, kidney, cardiac, or pulmonary disease;
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- a terminal medical diagnosis consistent with survival 1 year;
- coexistent major neurological or psychiatric disease (to decrease the number of confounders);
- a history of significant drug abuse in the prior 6 months;
- the use of certain neuropsychotropic drugs such as tricyclics, antidepressants, or 51 of 66 carbamazepine;
- active enrollment in a separate intervention study targeting stroke recovery; (
- previously applied constraint-induced motor therapy and/or tDCS treatment for stroke; and
- a history of epilepsy before stroke (or episodes of seizures within the last six months).
About this study
Official title: The Effect of Transcranial Direct Current Stimulation Combined With Functional Task Training on Motor Recovery in Stroke Patients
We propose to enhance the effects of brain plasticity using a powerful noninvasive technique for brain modulation consisting of navigated transcranial magnetic stimulation (TMS) priming with transcranial direct current stimulation (tDCS) in combination with motor-training-like constraint-induced movement therapy (CIMT).
- Conditions
- Stroke, Stroke, Acute, Motor Function
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), Transcranial Direct Current Stimulation (tDCS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Subjects will either undergo (1) active low-frequency rTMS (1Hz continuous) prime with anodal Transcranial Direct Current Stimulation (tDCS) on the affected side combine with Constraint induced movement therapy. Each session will last 20 minutes.
Transcranial Direct Current Stimulation (tDCSDevice
Subjects will either undergo sham Transcranial Direct Current Stimulation (tDCS) on the affected side combine with Constraint-induced movement therapy.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Not described Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Transcranial Direct Current Stimulation (tDCS |
| Sham | Sham comparator | Not described Receives: Device: Transcranial Direct Current Stimulation (tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the neurophysiologic findings of cortical plasticity.
Expressed as percent motor resting threshold and numerical values of motor evoked potential. The motor evoked potential (MEP) will be provided by twenty unconditioned stimuli (120% of motor resting threshould). The percentage of inhibition or facilitation for each before and after stimulation will be calculated.
Measured: Before 10 sessions, before and after each session (every day), after 10 daily sessions and after 6 weeks
To assess the motor function changes .
Change from motor hand function: ordinal variable measured through the Jebsen-Taylor Hand Function Test (JTHFT). The JTHFT has seven subsets which are writing, simulated page-turning, lifting small objects, simulated feeding, stacking, and lifting large, lightweight, and heavy objects
Measured: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days
Secondary outcomes (2)
Sensory-motor function of the upper limb
This consists of a quantitative scale developed to measure (motor recovery, balance, sensation, and some joint function) recovery of the motor function of stroke patients. Measured through the Fugl-Meyer Rating Scale, which expressed in values from 0 to 66.
Measured: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days
Degree of disability:
This consists of a quantitative scale developed to measured the disability caused by impairments in stroke patients. The Barthel Index Score (Activities of Daily Living) measured through ranges from 0 to 20, principally concerned with physical aspects of disability.
Measured: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Fahad Specialist Hospital Dammam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646577
- Sponsor's protocol ID
- NEU0329
- Status last verified
- Nov 2020
- First submitted
- 6 Oct 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Al-Hussain F, Nasim E, Iqbal M, Altwaijri N, Asim N, Yoo WK, Bashir S. The effect of transcranial direct current stimulation combined with functional task training on motor recovery in stroke patients. Medicine (Baltimore). 2021 Feb 12;100(6):e24718. doi: 10.1097/MD.0000000000024718.
PubMed 33578615
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Direct Current Stimulation Combined With Functional Task Training on Motor Recovery in Stroke Patients
- ClinicalTrials.gov ID
- NCT04646577
- Acronym / sponsor ID
- NEU0329
- Conditions
- Stroke, Stroke, Acute, Motor Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- King Fahad Specialist Hospital DammamUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 30 Nov 2020 (actual)
- 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.
We propose to enhance the effects of brain plasticity using a powerful noninvasive technique for brain modulation consisting of navigated transcranial magnetic stimulation (TMS) priming with transcranial direct current stimulation (tDCS) in combination with motor-training-like constraint-induced movement therapy (CIMT).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Device: Transcranial Direct Current Stimulation (tDCS |
| Sham | Sham comparator | Device: Transcranial Direct Current Stimulation (tDCS |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18-90
- first-time clinical ischemic or hemorrhagic cerebrovascular accident as noted in the radiological (or physician's) report;
- the ability to extend =20° at the wrist and 10° at the metacarpophalangeal and interphalangeal joints of all digits;
- participants must demonstrate adequate balance while wearing the restraint;
- the ability to stand from a sitting position and the ability to stand for at least 2 minutes with or without upper extremity support;
Key exclusion criteria (13 listed)
- significant pre-stroke disability;
- where applicable (a history of depression before the stroke);
- any substantial decrease in alertness, language reception, or attention that might interfere with understanding the instructions for the motor testing;
- excessive pain in any joint of the paretic extremity;
- contraindications to single-pulse TMS (TMS will be used to measure cortical excitability) such as metal head implants;
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)Subjects will either undergo (1) active low-frequency rTMS (1Hz continuous) prime with anodal Transcranial Direct Current Stimulation (tDCS) on the affected side combine with Constraint induced movement therapy. Each session will last 20 minutes. | Device | Active |
| Transcranial Direct Current Stimulation (tDCSSubjects will either undergo sham Transcranial Direct Current Stimulation (tDCS) on the affected side combine with Constraint-induced movement therapy. | Device | Active, Sham |
Primary outcome
To assess the neurophysiologic findings of cortical plasticity.
Time frame: Before 10 sessions, before and after each session (every day), after 10 daily sessions and after 6 weeks
Expressed as percent motor resting threshold and numerical values of motor evoked potential. The motor evoked potential (MEP) will be provided by twenty unconditioned stimuli (120% of motor resting threshould). The percentage of inhibition or facilitation for each before and after stimulation will be calculated.
To assess the motor function changes .
Time frame: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days
Change from motor hand function: ordinal variable measured through the Jebsen-Taylor Hand Function Test (JTHFT). The JTHFT has seven subsets which are writing, simulated page-turning, lifting small objects, simulated feeding, stacking, and lifting large, lightweight, and heavy objects
2 secondary outcomes
Sensory-motor function of the upper limb
Time frame: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days
Degree of disability:
Time frame: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Derived from this study: PubMed 33578615Al-Hussain F, Nasim E, Iqbal M, Altwaijri N, Asim N, Yoo WK, Bashir S. The effect of transcranial direct current stimulation combined with functional task training on motor recovery in stroke patients. Medicine (Baltimore). 2021 Feb 12;100(6):e24718. doi: 10.1097/MD.0000000000024718.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) and Transcranial Direct Current Stimulation (tDCS in people with Stroke and Stroke, Acute, run by King Fahad Specialist Hospital Dammam.
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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
To assess the neurophysiologic findings of cortical plasticity. (time frame: Before 10 sessions, before and after each session (every day), after 10 daily sessions and after 6 weeks). The study lists 2 primary outcomes in all. 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 NCT04646577, which also lists 1 linked publication.
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 30 Nov 2020.