Clinical trial NCT04866771: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: University of Chicago
First posted: 2021-04-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Revised ALS Functioning Rating Scale (ALSFRS-R)
timeFrame: Change from baseline to immediately after training and baseline to 3 months follow up.
measure: Muscle Strength Testing
timeFrame: Change from baseline to immediately after training and baseline to 3 months follow up.
Secondary outcomes:
measure: Gait speed
timeFrame: Change from baseline to immediately after training and baseline to 3 months follow up.
measure: 10-meter walk
timeFrame: Change from baseline to immediately after training and baseline to 3 months follow up.
measure: Ankle motor control
timeFrame: Change from baseline to immediately after training and baseline to 3 months follow up.
measure: Quality of Life with EuroQol-5D (EQ-5D)
timeFrame: Change from baseline to immediately after training and baseline to 3 months follow up.
measure: EuroQual-Visual Analog Scale (EQ-VAS)
timeFrame: Change from baseline to immediately after training and baseline to 3 months follow up.
measure: Fatigue Severity Scale
timeFrame: Change from baseline to immediately after training and baseline to 3 months follow up.
measure: Upper and lower motor neuron mechanisms using transcranial magnetic stimulation (TMS)
timeFrame: Change from baseline to immediately after training and baseline to 3 months follow up.
measure: Upper and lower motor neuron mechanisms using peripheral nerve stimulation (PNS)
timeFrame: Change from baseline to immediately after training and baseline to 3 months follow up.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Brain Plasticity Lab
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Sangeetha Madhavan
role: PRINCIPAL_INVESTIGATOR
References: