Remotely Supervised tDCS for Slowing ALS Disease Progression
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Interventions
- Other: Transcranial Direct Current Stimulation (tDCS)Other: Sham tDCS + anodal tDCS
- 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
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
- Arm && Interventions
Group Intervention Description Transcranial Direct Current Stimulation (tDCS) Transcranial Direct Current Stimulation (tDCS) Facilitatory transcranial direct current stimulation (tDCS) Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group Sham tDCS + anodal tDCS Sham tDCS followed by a switch to anodal tDCS.
- Primary Outcome Measures
Name Time Method 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 0-40 with higher scores corresponding to more function being retained.
Muscle Strength Testing Change from baseline to immediately after training and baseline to 3 months follow up. 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
Name Time Method EuroQual-Visual Analog Scale (EQ-VAS) Change from baseline to immediately after training and baseline to 3 months follow up. 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.
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.
Fatigue Severity Scale Change from baseline to immediately after training and baseline to 3 months follow up. 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.
Gait speed Change from baseline to immediately after training and baseline to 3 months follow up. Self-selected and fast walking will be measured as the average walking speed from 2 trials of the 10-m walk test (10MWT).
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).
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.
10-meter walk Change from baseline to immediately after training and baseline to 3 months follow up. The 10-meter walk test (10MWT) is a performance measure used to assess walking speed in meters per second over a short distance.
Trial Locations
- Locations (1)
Brain Plasticity Lab
🇺🇸Chicago, Illinois, United States