Amyotrophic Lateral Sclerosis (ALS)NCT04866771
Remotely Supervised tDCS for Slowing ALS Disease Progression
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Amyotrophic Lateral Sclerosis (ALS), run by University of Illinois at Chicago at 1 site in United States.
Trial summary
Most ALS care is centered on patient support and symptom management, making rehabilitation an integral aspect for slowing disease progression, prolonging life span, and increasing quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2021to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of possible, probable, or definite amyotrophic lateral sclerosis according to El Escorial revised criteria
- Spinal onset ALS with initial weakness in the upper or lower extremity.
- Diagnosed with ALS within the past 5 years
- 1-2 point change in pre-slope of the ALSFRS-R at time of enrollment (ratio of drop in score from 48 to the duration in months from onset of weakness)
- Score ≥ 2 for "swallowing" of the ALSFRS-R
- Score ≥ 2 for "walking" of the ALSFRS-R
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- Able to provide informed consent
- Stable dose of riluzole, edaravone, AMX0035 (Relyvrio) or no medications
- Availability of a caregiver for remote administration of tDCS
Who cannot join
- Subject has bulbar onset ALS
- Any neurological diagnosis other than ALS
- Psychiatric disorders
- Any other concomitant disease that affects prognosis of ALS inclusive of systemic disease, cardiovascular disease, hepatic or renal disorder
- Tracheostomal or noninvasive ventilation for more than 12 hours per day
- Enrollment in an on-going ALS pharmaceutical trial
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- Subject plans on moving within 6 months.
- TMS Exclusion Criteria:
- Implanted cardiac pacemaker
- Metal implants in the head or face
- Unexplained, recurring headaches
- History of seizures or epilepsy
- Currently under medication that could increase motor excitability and lower seizure threshold
- Skull abnormalities or fractures
- Concussion within the last 6 months
- Currently pregnant
- tDCS Exclusion Criteria:
- Skin hypersensitivity
- History of contact dermatitis
- History of allodynia and/or hyperalgesia
- Any other skin or scalp condition that could be aggravated by tDCS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remotely Supervised Transcranial Direct Current Stimulation for Slowing Disease Progression in Amyotrophic Lateral Sclerosis (ALS)
Most ALS care is centered on patient support and symptom management, making rehabilitation an integral aspect for slowing disease progression, prolonging life span, and increasing quality of life. Brain stimulation has been increasingly explored as a promising neuromodulatory tool to prime motor function in several neurological disorders. We propose a novel mechanism using remotely supervised brain stimulation to preserve motor function in individuals with ALS. This project will also aim to explore the effectiveness of brain stimulation on upper and lower motor neuron mechanisms in individuals with ALS.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- Transcranial Direct Current Stimulation (tDCS), Sham tDCS + anodal tDCS
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Other
Also called Soterix Medical 1X1 tDCS mini-CT Stimulator
Noninvasive brain stimulation
Sham tDCS + anodal tDCSOther
Also called Soterix Medical 1X1 tDCS mini-CT Stimulator
Fake noninvasive brain stimulation or anodal noninvasive brain stimulation
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Experimental | Facilitatory transcranial direct current stimulation (tDCS) Receives: Other: Transcranial Direct Current Stimulation (tDCS) |
| Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group | Sham comparator | Sham tDCS followed by a switch to anodal tDCS. Receives: Other: Sham tDCS + anodal tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Revised ALS Functioning Rating Scale (ALSFRS-R)
This questionnaire evaluates function over time and disease progression in ALS patients with questions related to daily activities such as speech, swallowing, walking, etc. Scores range between 0-48 with higher scores corresponding to more function being retained.
Measured: Change from baseline to immediately after training and baseline to 3 months follow up.
Secondary outcomes (7)
Gait Speed
Self-selected will be measured as the average walking speed from 2 trials of the 10-m walk test (10MWT).
Measured: Change from baseline to immediately after training
Ankle Motor Control
The participant will track a computer-generated sinusoidal target with ankle dorsiflexion and plantarflexion in a custom-built ankle-tracking device. Accuracy of tracking the target with ankle motion will be calculated.
Measured: Change from baseline to immediately after training and baseline to 3 months follow up.
Quality of Life With EuroQol-5D (EQ-5D)
Quality of life will be measured with the EuroQol-5D (EQ-5D), a questionnaire with questions designed to assess aspects of quality of life.
Measured: Change from baseline to immediately after training and baseline to 3 months follow up.
EuroQual-Visual Analog Scale (EQ-VAS)
Quality of life will be measured using a visual analog scale with endpoints labeled, 'The best health you can imagine' and 'the worst health you can imagine' in response to questions related to aspects of quality of life. Scores range from 0 to 100, with higher values indicating better self-rated health status."
Measured: Change from baseline to immediately after training
Fatigue Severity Scale
9-item scale measuring severity of fatigue and its effect on participant's daily activities and lifestyle with higher scores representing more fatigue and fatigue playing a larger role in daily activities. Minimum score = 0 and maximum score = 63.
Measured: Change from baseline to immediately after training.
Upper and Lower Motor Neuron Mechanisms Using Transcranial Magnetic Stimulation (TMS)
Upper and lower motor neuron mechanisms of the tibialis anterior will be measured using single pulse transcranial magnetic stimulation (TMS). Measures may include motor evoked potential (MEP) amplitude, latency, and/or cortical silent period.
Measured: Change from baseline to immediately after training and baseline to 3 months follow up.
Upper and Lower Motor Neuron Mechanisms Using Peripheral Nerve Stimulation (PNS)
Upper and lower motor neuron mechanisms in ALS will also be assessed using peripheral nerve stimulation at either the knee or the elbow.
Measured: Change from baseline to immediately after training and baseline to 3 months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start27 Aug 2021
- Primary completion1 Jul 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago
- Responsible party
- Principal investigator, Sangeetha Madhavan, University of Illinois at Chicago
- Investigators
- Sangeetha Madhavan, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866771
- Sponsor's protocol ID
- 2021-0097
- Status last verified
- Jul 2025
- First submitted
- 30 Mar 2021
- Last updated
- 7 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Madhavan S, Deshmukh S, Cummings M, Doshi A, Rezania K, Freels S, Sawa G. Home-Based Tele-tDCS in Amyotrophic Lateral Sclerosis: Feasibility, Safety, and Preliminary Efficacy. Ann Clin Transl Neurol. 2025 May;12(5):1022-1033. doi: 10.1002/acn3.70038. Epub 2025 Mar 24.
PubMed 40125702
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Supervised Transcranial Direct Current Stimulation for Slowing Disease Progression in Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT04866771
- Acronym / sponsor ID
- 2021-0097
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- University of Chicago
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Posted 7 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most ALS care is centered on patient support and symptom management, making rehabilitation an integral aspect for slowing disease progression, prolonging life span, and increasing quality of life. Brain stimulation has been increasingly explored as a promising neuromodulatory tool to prime motor function in several neurological disorders. We propose a novel mechanism using remotely supervised brain stimulation to preserve motor function in individuals with ALS. This project will also aim to explore the effectiveness of brain stimulation on upper and lower motor neuron mechanisms in individuals with ALS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Experimental | Other: Transcranial Direct Current Stimulation (tDCS)Facilitatory transcranial direct current stimulation (tDCS) |
| Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group | Sham comparator | Other: Sham tDCS + anodal tDCSSham tDCS followed by a switch to anodal tDCS. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of possible, probable, or definite amyotrophic lateral sclerosis according to El Escorial revised criteria
- Spinal onset ALS with initial weakness in the upper or lower extremity.
- Diagnosed with ALS within the past 5 years
- 1-2 point change in pre-slope of the ALSFRS-R at time of enrollment (ratio of drop in score from 48 to the duration in months from onset of weakness)
- Score ≥ 2 for "swallowing" of the ALSFRS-R
Key exclusion criteria (21 listed)
- Subject has bulbar onset ALS
- Any neurological diagnosis other than ALS
- Psychiatric disorders
- Any other concomitant disease that affects prognosis of ALS inclusive of systemic disease, cardiovascular disease, hepatic or renal disorder
- Tracheostomal or noninvasive ventilation for more than 12 hours per day
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 |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Also: Soterix Medical 1X1 tDCS mini-CT StimulatorNoninvasive brain stimulation | Other | Transcranial Direct Current Stimulation (tDCS) |
| Sham tDCS + anodal tDCSAlso: Soterix Medical 1X1 tDCS mini-CT StimulatorFake noninvasive brain stimulation or anodal noninvasive brain stimulation | Other | Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group |
Primary outcome
Change in Revised ALS Functioning Rating Scale (ALSFRS-R)
Time frame: Change from baseline to immediately after training and baseline to 3 months follow up.
This questionnaire evaluates function over time and disease progression in ALS patients with questions related to daily activities such as speech, swallowing, walking, etc. Scores range between 0-48 with higher scores corresponding to more function being retained.
7 secondary outcomes
Gait Speed
Time frame: Change from baseline to immediately after training
Ankle Motor Control
Time frame: Change from baseline to immediately after training and baseline to 3 months follow up.
Quality of Life With EuroQol-5D (EQ-5D)
Time frame: Change from baseline to immediately after training and baseline to 3 months follow up.
EuroQual-Visual Analog Scale (EQ-VAS)
Time frame: Change from baseline to immediately after training
Fatigue Severity Scale
Time frame: Change from baseline to immediately after training.
Upper and Lower Motor Neuron Mechanisms Using Transcranial Magnetic Stimulation (TMS)
Time frame: Change from baseline to immediately after training and baseline to 3 months follow up.
Upper and Lower Motor Neuron Mechanisms Using Peripheral Nerve Stimulation (PNS)
Time frame: Change from baseline to immediately after training and baseline to 3 months follow up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40125702Madhavan S, Deshmukh S, Cummings M, Doshi A, Rezania K, Freels S, Sawa G. Home-Based Tele-tDCS in Amyotrophic Lateral Sclerosis: Feasibility, Safety, and Preliminary Efficacy. Ann Clin Transl Neurol. 2025 May;12(5):1022-1033. doi: 10.1002/acn3.70038. Epub 2025 Mar 24.
- Individual participant dataSharing planned: No
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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.
Sangeetha Madhavan principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Amyotrophic Lateral Sclerosis (ALS), run by University of Illinois at Chicago at 1 site in United States.
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 9 inclusion and 21 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 7 Aug 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 States. 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?
Yes. Results are posted in the registry (first posted 7 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Revised ALS Functioning Rating Scale (ALSFRS-R) (time frame: Change from baseline to immediately after training and baseline to 3 months follow up.). 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 NCT04866771, 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 7 Aug 2025.