Clinical trial NCT03981055: Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability.
Official title: Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Highland Instruments, Inc.
First posted: 2019-06-10
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This trial aims to understand the mechanism and to test whether transcranial direct current stimulation (tDCS) combined with transcranial ultrasound (TUS) (tDCS+TUS) combined with physical therapy (PT) will induce significant therapeutic effects in postural instability in Parkinson's disease (PT) patients. The investigators designed a double-blinded, placebo controlled, randomized study to investigate the effects of 2 weeks of TDCS+TUS on postural instability in PD patients receiving PT. (Followed by biweekly sessions for 2 more weeks in Phase II)

Detailed description: Current treatments for Parkinson's Disease (PD), including pharmacological (levodopa) and surgical (DBS) methods, have limited impact on postural instability. Physical therapy (PT) for PD is becoming increasingly used as a means to induce benefits on patient balance. However, limits in efficacy and consistency still exist. In this study, the investigators will test the effects of TDCS+TUS combined with PT on postural instability of PD patients.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of "probable" or "possible" PD, as defined by the current clinical criteria (Gelb D, Oliver E, Gilman S. Diagnostic Criteria for Parkinson's Disease. Arch Neurol.1999;56:33-39) as confirmed by co-investigator neurologist, or confirmation via medical records or a letter from patient physician;
2. Complaints about balance impairment or postural instability due to PD (self-report);
3. Age from 40 to 90 years old;
4. Taking stable medications for PD for at least 30 days.

Exclusion Criteria:

1. Features suggestive of other causes of parkinsonism/Parkinson's-plus syndromes;
2. History of deep brain stimulation or brain ablation surgeries, malignant mass brain lesions;
3. History of schizophrenia, bipolar illness; history of alcohol/drug abuse within the past 6 months;
4. Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality;
5. Contraindications to transcranial brain stimulation or TUS, i.e. metal in the head, implanted brain medical devices, etc.;
6. Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, uncompensated pulmonary disease, or chronic obstructive pulmonary disease);
7. Pregnancy.
8. Epilepsy or disorders that significantly increase likelihood of seizures including: severe traumatic brain injury, congenital birth defects leading to seizures, brain tumor, metabolic disorders associated with seizures, intracranial or subarachnoid hemorrhage, and nonlacunar strokes.
9. Recent (\<= 2 months) or planned enrollment in an additional physician prescribed physical therapy program during their time in the trial.
10. Presence of another disorder that might have a significant impact on balance (as assessed by a co-investigator neurologist).
11. Bed or wheelchair-bound

Primary outcomes:
measure: Change in postural sway
timeFrame: 1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
measure: Leg Agility
timeFrame: 1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
measure: Arising from a chair
timeFrame: 1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
measure: Balance
timeFrame: 1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
measure: Gait
timeFrame: 1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
measure: Toe tapping
timeFrame: 1 week pre intervention, immediately before intervention, following stimulation treatment (stimulation day 5, 10 and 14), and all follow ups
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Spaulding Rehabilitation Network Research Institute
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Felipe Fregni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: