Trial Outcomes & Findings for Remotely Supervised tDCS for Slowing ALS Disease Progression (NCT NCT04866771)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

Change from baseline to immediately after training and baseline to 3 months follow up.

Results posted on

2025-08-07

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Transcranial Direct Current Stimulation (tDCS) Facilitatory transcranial direct current stimulation (tDCS)	Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group Sham tDCS followed by a switch to anodal tDCS.
Overall Study STARTED	7	7
Overall Study COMPLETED	7	3
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transcranial Direct Current Stimulation (tDCS) n=7 Participants Facilitatory transcranial direct current stimulation (tDCS)	Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group n=7 Participants Sham tDCS followed by a switch to anodal tDCS.	Total n=14 Participants Total of all reporting groups
Age, Continuous	53 years STANDARD_DEVIATION 9 • n=7 Participants	55 years STANDARD_DEVIATION 10 • n=7 Participants	54 years STANDARD_DEVIATION 9 • n=14 Participants
Sex: Female, Male Female	3 Participants n=7 Participants	4 Participants n=7 Participants	7 Participants n=14 Participants
Sex: Female, Male Male	4 Participants n=7 Participants	3 Participants n=7 Participants	7 Participants n=14 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Change from baseline to immediately after training and baseline to 3 months follow up.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Transcranial Direct Current Stimulation (tDCS) n=7 Participants Facilitatory transcranial direct current stimulation (tDCS)	Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group n=7 Participants Sham tDCS followed by a switch to anodal tDCS.
Change in Revised ALS Functioning Rating Scale (ALSFRS-R) Pre to Post	-1 Change score on ALSFRS-R Standard Error 1.06	-7.1 Change score on ALSFRS-R Standard Error 1.56
Change in Revised ALS Functioning Rating Scale (ALSFRS-R) Pre to 3 month follow up	-3.2 Change score on ALSFRS-R Standard Error 2	-7.1 Change score on ALSFRS-R Standard Error 1.56

SECONDARY outcome

Timeframe: Change from baseline to immediately after training

Population: 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

Self-selected will be measured as the average walking speed from 2 trials of the 10-m walk test (10MWT).

Outcome measures

Outcome measures
Measure	Transcranial Direct Current Stimulation (tDCS) n=6 Participants Facilitatory transcranial direct current stimulation (tDCS)	Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group n=2 Participants Sham tDCS followed by a switch to anodal tDCS.
Gait Speed	-0.11 m/s Standard Error 0.1	-0.30 m/s Standard Error 0.08

SECONDARY outcome

Timeframe: Change from baseline to immediately after training and baseline to 3 months follow up.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to immediately after training and baseline to 3 months follow up.

Quality of life will be measured with the EuroQol-5D (EQ-5D), a questionnaire with questions designed to assess aspects of quality of life.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to immediately after training

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."

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to immediately after training.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to immediately after training and baseline to 3 months follow up.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to immediately after training and baseline to 3 months follow up.

Upper and lower motor neuron mechanisms in ALS will also be assessed using peripheral nerve stimulation at either the knee or the elbow.

Outcome measures

Outcome data not reported

Adverse Events

Transcranial Direct Current Stimulation (tDCS)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Transcranial Direct Current Stimulation (tDCS) n=7 participants at risk Facilitatory transcranial direct current stimulation (tDCS)	Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group n=7 participants at risk Sham tDCS followed by a switch to anodal tDCS.
Skin and subcutaneous tissue disorders Itching	71.4% 5/7 • 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.	42.9% 3/7 • 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.
Skin and subcutaneous tissue disorders Tingling	85.7% 6/7 • 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.	57.1% 4/7 • 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.

Additional Information

PRS Training Lead

University Of Illinois At Chicago

Phone: (312) 996-4995

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place