Remotely Supervised tDCS for Slowing ALS Disease Progression

Not Applicable

Completed

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Registration Number: NCT04866771

Lead Sponsor: University of Illinois at Chicago

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 14

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Revised ALS Functioning Rating Scale (ALSFRS-R)	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.

Secondary Outcome Measures

Name	Time	Method
Ankle Motor Control	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.
Quality of Life With EuroQol-5D (EQ-5D)	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.
Gait Speed	Change from baseline to immediately after training	Self-selected will be measured as the average walking speed from 2 trials of the 10-m walk test (10MWT).
EuroQual-Visual Analog Scale (EQ-VAS)	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."
Fatigue Severity Scale	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.
Upper and Lower Motor Neuron Mechanisms Using Transcranial Magnetic Stimulation (TMS)	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.
Upper and Lower Motor Neuron Mechanisms Using Peripheral Nerve Stimulation (PNS)	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.