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Behavioural Intervention

Real tPCS for Parkinson's Disease

N/A
Waitlist Available
Led By Mandar Jog, MD
Research Sponsored by Western University, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients diagnosed with Idiopathic Parkinson's disease (IPD).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

A significant number of patients with Parkinson's disease (PD) face motor fluctuations even after repeated titration of the dosing of Levodopa. Dealing with OFF state really becomes problematic for them. Aggravation of bradykinesia, rigidity, tremor and gait difficulty are the common problems in OFF state. Studies are going on drugs like Apomorphine as rescue therapy in OFF state. Recently there are studies with Noninvasive brain stimulation, as an evolving therapeutic option in different neurodegenerative diseases. In this study, the investigators are to evaluate the efficacy of transcranial pulsed current stimulation (tPCS) in the OFF state in PD patients. The investigators will give stimulation via tPCS (active/sham). EEG, Kinematic measurement of upper limb movement via KinArm, Unified Parkinson's Disease Rating Scale (UPDRS) scoring will be done and gait will be assessed via Gait Carpet - pre and post-stimulation. The investigators will evaluate the effectiveness of tPCS as a single modality or in combination with Levodopa in managing OFF state of PD.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Unified Parkinson's disease rating scale (UPDRS) part III
Change in upper limb motor kinetics
Changes in Network fragmentation using Quantitative Electroencephalography (EEG)
+1 more

Side effects data

From 2015 Phase 3 trial • 31 Patients • NCT01960842
42%
INCISION SITE PAIN
32%
EXCESSIVE GRANULATION TISSUE
19%
CONSTIPATION
19%
DIARRHOEA
19%
NASOPHARYNGITIS
19%
FALL
16%
DYSKINESIA
16%
PROCEDURAL PAIN
16%
BLOOD HOMOCYSTEINE INCREASED
13%
INCISION SITE ERYTHEMA
10%
ANAEMIA
10%
TINEA PEDIS
10%
ANXIETY
6%
PNEUMONIA ASPIRATION
6%
ABDOMINAL DISTENSION
6%
ABDOMINAL PAIN UPPER
6%
TOOTHACHE
6%
STOMA SITE INFECTION
6%
BLOOD PRESSURE DECREASED
6%
WEIGHT DECREASED
6%
INSOMNIA
6%
EPISTAXIS
6%
OROPHARYNGEAL PAIN
6%
HEADACHE
6%
COMPLICATION OF DEVICE INSERTION
6%
PYREXIA
6%
INCISION SITE RASH
6%
SUTURE RELATED COMPLICATION
6%
MUSCULOSKELETAL PAIN
6%
ECZEMA
6%
PRURITUS
3%
DEVICE KINK
3%
VITREOUS FLOATERS
3%
GASTROINTESTINAL PERFORATION
3%
MELAENA
3%
DEVICE DISLOCATION
3%
CARDIAC VALVE DISEASE
3%
DENTAL CARIES
3%
DRY MOUTH
3%
GASTRIC ULCER
3%
GASTROOESOPHAGEAL REFLUX DISEASE
3%
ILEUS
3%
CATHETER SITE PAIN
3%
SKIN ABRASION
3%
SEPSIS
3%
FEMUR FRACTURE
3%
ABDOMINAL PAIN
3%
PNEUMOPERITONEUM
3%
CATHETER SITE PRURITUS
3%
CHEST PAIN
3%
INCISION SITE CELLULITIS
3%
INCISION SITE INFECTION
3%
RHINITIS
3%
SIALOADENITIS
3%
STOMA SITE CELLULITIS
3%
CONTUSION
3%
INCISION SITE DERMATITIS
3%
LACERATION
3%
POSTOPERATIVE ILEUS
3%
RIB FRACTURE
3%
BLOOD GLUCOSE INCREASED
3%
BLOOD PRESSURE INCREASED
3%
BLOOD TRIGLYCERIDES INCREASED
3%
BACK PAIN
3%
FOOT DEFORMITY
3%
LUMBAR SPINAL STENOSIS
3%
MUSCULOSKELETAL CHEST PAIN
3%
METABOLIC ENCEPHALOPATHY
3%
MIGRAINE
3%
RESTLESS LEGS SYNDROME
3%
AGITATION
3%
HEAD BANGING
3%
ILLUSION
3%
NIGHTMARE
3%
DYSURIA
3%
DYSPNOEA
3%
PALPITATIONS
3%
ABDOMINAL DISCOMFORT
3%
HYPONATRAEMIA
3%
MALNUTRITION
3%
RADICULOPATHY
3%
PRODUCTIVE COUGH
3%
DISSEMINATED INTRAVASCULAR COAGULATION
3%
DYSTONIA
3%
NAUSEA
3%
STOMATITIS
3%
CHEST DISCOMFORT
3%
ALVEOLAR OSTEITIS
3%
BODY TINEA
3%
CATHETER SITE INFECTION
3%
SCRATCH
3%
STOMA SITE ERYTHEMA
3%
TOOTH FRACTURE
3%
WOUND COMPLICATION
3%
DECREASED APPETITE
3%
DIABETES MELLITUS
3%
MYALGIA
3%
PAIN IN EXTREMITY
3%
POSTURE ABNORMAL
3%
CARPAL TUNNEL SYNDROME
3%
CEREBRAL INFARCTION
3%
RHINORRHOEA
3%
ACNE
3%
DERMATITIS CONTACT
3%
DRY SKIN
3%
HYPERHIDROSIS
3%
PETECHIAE
3%
PRURITUS GENERALISED
3%
SKIN ULCER
3%
HYPERTENSION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Levodopa-Carbidopa Intestinal Gel (LCIG)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Real tPCSExperimental Treatment1 Intervention
Patients will be randomized to any of the 3 arms. In Real tPCS arm, we will give active tPCS for 20 mins.
Group II: LevodopaActive Control1 Intervention
Patients will be randomized to any of the 3 arms. In Levodopa arm, we will give 3 tablets of Levodopa-Carbidopa (100/25).
Group III: Sham tPCSPlacebo Group1 Intervention
Patients will be randomized to any of the 3 arms. In Sham tPCS arm, we will give sham tPCS for 20 mins.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active tPCS
2018
Completed Phase 1
~70

Find a Location

Who is running the clinical trial?

Western University, CanadaLead Sponsor
239 Previous Clinical Trials
57,468 Total Patients Enrolled
Mandar Jog, MDPrincipal InvestigatorLondon Health Sciences Centre
7 Previous Clinical Trials
459 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Trial of tPCS on Parkinson's Disease OFF State
Mandar Jog 2019. "A Trial of tPCS on Parkinson's Disease OFF State". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04054960.
All > Parkinson
~3 spots leftby Apr 2025
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