FatigueTIPSNCT04634864
Transcranial Direct Current Stimulation in Post-stroke Fatigue
A study testing Anodal tDCS in people with Fatigue and Stroke, run by University College, London at 1 site in United Kingdom.
Trial summary
This is a double-blind, sham-controlled, anodal tDCS study to understand the effect of increasing motor cortex excitability on post-stroke fatigue. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Anodal tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jan 2018to 8 Aug 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with stroke at least 3 months post-stroke
Who cannot join
- Other neurological conditions on Anti-depressants severe motor impairment (affected hand grip <60% unaffected hand) severe cognitive impairment (unable to follow instructions, or give informed consent) scored >11 in the depression sub-section of HADS questionnaire contraindications for TMS or tES
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
33 Queen Square, Institute of Neurology, UCL
London, WC1N 3BG
About this study
Official title: tDCS in Post-stroke Fatigue: a Double Blind, Sham-controlled, Bilateral Anodal Motor Cortical Stimulation Study
This is a double-blind, sham-controlled, anodal tDCS study to understand the effect of increasing motor cortex excitability on post-stroke fatigue.
- Being tested
- Anodal tDCS, sham tDCS
- Medical subject headings
- Fatigue, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCSDevice
40 minutes of 2mA intensity direct current stimulation was delivered over both the right and left motor cortex simultaneously
sham tDCSDevice
The stimulator was switched off after 2 minutes of stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Active comparator | 40 minutes of 2mA intensity direct current stimulation Receives: Device: Anodal tDCS |
| sham tDCS | Sham comparator | 40 minutes of 0mA intensity. the session starts with a ramp up to 2mA, but machine is switched off after 2 minutes of stimulation. Receives: Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale - 7
a questionnaire based fatigue scale
Measured: 2 weeks
Secondary outcomes (4)
Resting Motor Threshold
This is a measure of cortical excitability as measured by transcranial magnetic stimulation
Measured: 1 day
Input-output curves
This is a measure of cortical recruitment as measured by transcranial magnetic stimulation
Measured: 1 day
Perceived effort - Explicit
A VAS scale associated with a grip task
Measured: 1 day
Perceived effort - Implicit
A novel line length estimation task
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start10 Jan 2018
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
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 FatigueStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634864
- Sponsor's protocol ID
- 195246
- Acronym
- TIPS
- Status last verified
- Nov 2020
- First submitted
- 12 Nov 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Doncker W, Ondobaka S, Kuppuswamy A. Effect of transcranial direct current stimulation on post-stroke fatigue. J Neurol. 2021 Aug;268(8):2831-2842. doi: 10.1007/s00415-021-10442-8. Epub 2021 Feb 17.
PubMed 33598767
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tDCS in Post-stroke Fatigue: a Double Blind, Sham-controlled, Bilateral Anodal Motor Cortical Stimulation Study
- ClinicalTrials.gov ID
- NCT04634864
- Acronym / sponsor ID
- TIPS / 195246
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 18 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.
This is a double-blind, sham-controlled, anodal tDCS study to understand the effect of increasing motor cortex excitability on post-stroke fatigue.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Active comparator | Device: Anodal tDCS40 minutes of 2mA intensity direct current stimulation |
| sham tDCS | Sham comparator | Device: sham tDCS40 minutes of 0mA intensity. the session starts with a ramp up to 2mA, but machine is switched off after 2 minutes of stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with stroke at least 3 months post-stroke
Key exclusion criteria (1 listed)
- Other neurological conditions on Anti-depressants severe motor impairment (affected hand grip <60% unaffected hand) severe cognitive impairment (unable to follow instructions, or give informed consent) scored >11 in the depression sub-section of HADS questionnaire contraindications for TMS or tES
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 |
|---|---|---|
| Anodal tDCS40 minutes of 2mA intensity direct current stimulation was delivered over both the right and left motor cortex simultaneously | Device | Anodal tDCS |
| sham tDCSThe stimulator was switched off after 2 minutes of stimulation. | Device | sham tDCS |
Primary outcome
Fatigue Severity Scale - 7
Time frame: 2 weeks
a questionnaire based fatigue scale
4 secondary outcomes
Resting Motor Threshold
Time frame: 1 day
Input-output curves
Time frame: 1 day
Perceived effort - Explicit
Time frame: 1 day
Perceived effort - Implicit
Time frame: 1 day
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 18 Nov 2020.
- Derived from this study: PubMed 33598767De Doncker W, Ondobaka S, Kuppuswamy A. Effect of transcranial direct current stimulation on post-stroke fatigue. J Neurol. 2021 Aug;268(8):2831-2842. doi: 10.1007/s00415-021-10442-8. Epub 2021 Feb 17.
Related trials for Fatigue
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Not yet recruitingObservational study
Inflammatory and Neuroimmune Guided Investigation of Underlying Fatigue in Patients With Cirrhosis
Cirrhosis Alcoholic, Fatigue Symptom
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruiting
Mobile-Based Resilience Intervention for Moral Injury, Compassion Fatigue, and Distress in ICU Nurses
Moral Injury
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tDCS in people with Fatigue and Stroke, run by University College, London 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 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 18 Nov 2020. 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?
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?
Fatigue Severity Scale - 7 (time frame: 2 weeks). 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 NCT04634864, 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 18 Nov 2020.