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Remotely Supervised tDCS for Slowing ALS Disease Progression

Primary Purpose

Amyotrophic Lateral Sclerosis (ALS)

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation (tDCS)
Sham tDCS + anodal tDCS
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis (ALS)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of 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 24 months
  • 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)
  • Slow vital capacity greater than or equal to 40% of predicted value
  • Score ≥ 2 for "swallowing" of the ALSFRS-R
  • Score ≥ 2 for "walking" of the ALSFRS-R
  • Able to provide informed consent
  • Stable dose of riluzole or edaravone or no medications
  • Availability of a caregiver for remote administration of tDCS

Exclusion Criteria:

  • 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
  • Subject plans on moving within 3 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

Sites / Locations

  • Brain Plasticity Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial Direct Current Stimulation (tDCS)

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

Arm Description

Facilitatory transcranial direct current stimulation (tDCS)

Sham tDCS followed by a switch to anodal tDCS.

Outcomes

Primary Outcome Measures

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 0-40 with higher scores corresponding to more function being retained.
Muscle Strength Testing
Maximum strength of bilateral ankle dorsiflexors and knee extensors will be tested using a hand-held dynamometer and using the Medical Research Council (MRC) Scale for muscle strength.

Secondary Outcome Measures

Gait speed
Self-selected and fast walking will be measured as the average walking speed from 2 trials of the 10-m walk test (10MWT).
10-meter walk
The 10-meter walk test (10MWT) is a performance measure used to assess walking speed in meters per second over a short distance.
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.
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.
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.
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.
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).
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.

Full Information

First Posted
March 30, 2021
Last Updated
October 9, 2023
Sponsor
University of Illinois at Chicago
Collaborators
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04866771
Brief Title
Remotely Supervised tDCS for Slowing ALS Disease Progression
Official Title
Remotely Supervised Transcranial Direct Current Stimulation for Slowing Disease Progression in Amyotrophic Lateral Sclerosis (ALS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis (ALS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Direct Current Stimulation (tDCS)
Arm Type
Experimental
Arm Description
Facilitatory transcranial direct current stimulation (tDCS)
Arm Title
Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group
Arm Type
Sham Comparator
Arm Description
Sham tDCS followed by a switch to anodal tDCS.
Intervention Type
Other
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)
Other Intervention Name(s)
Soterix Medical 1X1 tDCS mini-CT Stimulator
Intervention Description
Noninvasive brain stimulation
Intervention Type
Other
Intervention Name(s)
Sham tDCS + anodal tDCS
Other Intervention Name(s)
Soterix Medical 1X1 tDCS mini-CT Stimulator
Intervention Description
Fake noninvasive brain stimulation or anodal noninvasive brain stimulation
Primary Outcome Measure Information:
Title
Revised ALS Functioning Rating Scale (ALSFRS-R)
Description
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 0-40 with higher scores corresponding to more function being retained.
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up.
Title
Muscle Strength Testing
Description
Maximum strength of bilateral ankle dorsiflexors and knee extensors will be tested using a hand-held dynamometer and using the Medical Research Council (MRC) Scale for muscle strength.
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up.
Secondary Outcome Measure Information:
Title
Gait speed
Description
Self-selected and fast walking will be measured as the average walking speed from 2 trials of the 10-m walk test (10MWT).
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up.
Title
10-meter walk
Description
The 10-meter walk test (10MWT) is a performance measure used to assess walking speed in meters per second over a short distance.
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up.
Title
Ankle motor control
Description
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.
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up.
Title
Quality of Life with EuroQol-5D (EQ-5D)
Description
Quality of life will be measured with the EuroQol-5D (EQ-5D), a questionnaire with questions designed to assess aspects of quality of life.
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up.
Title
EuroQual-Visual Analog Scale (EQ-VAS)
Description
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.
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up.
Title
Fatigue Severity Scale
Description
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.
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up.
Title
Upper and lower motor neuron mechanisms using transcranial magnetic stimulation (TMS)
Description
Upper and lower motor neuron mechanisms of the tibialis anterior will be measured using single pulse transcranial magnetic stimulation (TMS).
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up.
Title
Upper and lower motor neuron mechanisms using peripheral nerve stimulation (PNS)
Description
Upper and lower motor neuron mechanisms in ALS will also be assessed using peripheral nerve stimulation at either the knee or the elbow.
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Able to provide informed consent Stable dose of riluzole, edaravone, AMX0035 (Relyvrio) or no medications Availability of a caregiver for remote administration of tDCS Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangeetha Madhavan
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain Plasticity Lab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Remotely Supervised tDCS for Slowing ALS Disease Progression

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