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| Name | Class |
|---|---|
| University of Chicago | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Experimental | Facilitatory 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Other | Noninvasive brain stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to immediately after training and baseline to 3 months follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Speed | Self-selected will be measured as the average walking speed from 2 trials of the 10-m walk test (10MWT). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
TMS Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sangeetha Madhavan | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Plasticity Lab | Chicago | Illinois | 60305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40125702 | Derived | 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. |
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A total of 70 individuals were assessed for eligibility. Of these, 56 were excluded prior to randomization: 48 did not meet eligibility criteria and 8 declined to participate or were unable to commit due to logistical reasons. Fourteen participants were randomized (7 to the intervention group and 7 to the delayed-start group). All eligibility assessments and consent were conducted remotely or in person before randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcranial Direct Current Stimulation (tDCS) | Facilitatory transcranial direct current stimulation (tDCS) |
| FG001 | Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group | Sham tDCS followed by a switch to anodal tDCS. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcranial Direct Current Stimulation (tDCS) | Facilitatory transcranial direct current stimulation (tDCS) |
| BG001 | Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analyses were conducted on an intent-to-treat basis, including all randomized participants who received at least one session. Missing data were handled using the last observation carried forward (LOCF) approach. | Posted | Mean | Standard Error | Change score on ALSFRS-R | Change from baseline to immediately after training and baseline to 3 months follow up. |
|
24 weeks during intervention and 3-month follow-up period (total of ~36 weeks)
Adverse events were monitored during each remotely supervised session using a structured questionnaire. Participants rated local and systemic symptoms (e.g., itching, tingling, redness) on a 0-4 scale. Definitions of adverse and serious adverse events aligned with ClinicalTrials.gov guidelines.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transcranial Direct Current Stimulation (tDCS) | Facilitatory transcranial direct current stimulation (tDCS) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRS Training Lead | University Of Illinois At Chicago | (312) 996-4995 | awards@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2023 | Jul 21, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Sham tDCS + anodal tDCS | Other | Fake noninvasive brain stimulation or anodal noninvasive brain stimulation |
|
|
| 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. | 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." | 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. | 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. | 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. | Change from baseline to immediately after training and baseline to 3 months follow up. |
Sham tDCS followed by a switch to anodal tDCS.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 |
| Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group |
Sham tDCS followed by a switch to anodal tDCS. |
|
|
| Secondary | Gait Speed | Self-selected will be measured as the average walking speed from 2 trials of the 10-m walk test (10MWT). | Gait speed data were collected for participants who were able to complete the 10MWT. Participants (n=6) who were non-ambulatory and could not perform the test at baseline or follow-up, and were therefore excluded from this analysis. Participants who withdrew from the study or did not complete the intervention are also not included in the analyses | Posted | Mean | Standard Error | m/s | Change from baseline to immediately after training |
|
|
|
| Secondary | 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. | Not Posted | Dec 2026 | Change from baseline to immediately after training and baseline to 3 months follow up. | Participants |
| Secondary | 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. | Not Posted | Dec 2026 | Change from baseline to immediately after training and baseline to 3 months follow up. | Participants |
| Secondary | 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." | Not Posted | Dec 2026 | Change from baseline to immediately after training | Participants |
| Secondary | 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. | Not Posted | Dec 2026 | Change from baseline to immediately after training. | Participants |
| Secondary | 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. | Not Posted | Dec 2026 | Change from baseline to immediately after training and baseline to 3 months follow up. | Participants |
| Secondary | 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. | Not Posted | Dec 2026 | Change from baseline to immediately after training and baseline to 3 months follow up. | Participants |
| 0 |
| 7 |
| 0 |
| 7 |
| 6 |
| 7 |
| EG001 | Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group | Sham tDCS followed by a switch to anodal tDCS. | 0 | 7 | 0 | 7 | 5 | 7 |
| Tingling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |