Group Therapy With Transcranial Direct Current Stimulation in Patients With Parkinson's Disease (GTBQ-PD)
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GTO
GT-tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring tDCS, Quality of Life, Parkinson Disease, Neuronal Plasticity
Eligibility Criteria
Inclusion Criteria:
- Presence of mild neurocognitive disorders was based on the validated Montreal Cognitive Assessment (MoCA) cutoff scores (<23.5)
- Based on the Hoehn-Yahr Stage (HYS) staging, severity of PD was categorized as mild (HYS 1&2), moderate (HYS 3) and severe (HYS 4&5). Patient with PD with mild and moderate will be recruited
Exclusion Criteria:
- Patient with PD with associated comorbidities such as stroke, uncontrolled diabetes, sensory impairments such as hearing, vision, etc.
- Patient with PD who is not willing to participate in the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group therapy only (GTO)
Group therapy with tDCS (GT-tDCS)
Arm Description
Patients in GTO group will receive structured group therapy programme
Patients in this group will receive group therapy along-with tDCS intervention
Outcomes
Primary Outcome Measures
Movement Disorders Society Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
The Unified Parkinson Disease Rating Scale, designed to monitor the burden and extent of Parkinson's disease. o-4 score, lower the score indicates normal, higher the scores indicate greater impact of PD symptoms.
Parkinson's Disease Questionnaire with 39 items
The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month.
Assesses how often patients experience difficulties across the 8 quality of life dimensions.
Assesses impact of Parkinson's Disease (PD) on specific dimensions of functioning and well-being. Each dimension total score ranges from 0 (never have difficulty) to 100 (always have difficulty). lower score reflect better quality of life.
Secondary Outcome Measures
Full Information
NCT ID
NCT04174573
First Posted
November 20, 2019
Last Updated
September 30, 2021
Sponsor
Maharishi Markendeswar University (Deemed to be University)
1. Study Identification
Unique Protocol Identification Number
NCT04174573
Brief Title
Group Therapy With Transcranial Direct Current Stimulation in Patients With Parkinson's Disease
Acronym
GTBQ-PD
Official Title
Efficacy of Group Therapy With Transcranial Direct Current Stimulation on Balance and Quality of Life in Patients With Parkinson's Disease: A Single Blind, Multi-centre, Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 6, 2022 (Anticipated)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maharishi Markendeswar University (Deemed to be University)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the effectiveness of group therapy along with transcranial direct current (tDCS) stimulation on motor symptoms, balance and quality of life in patients with Parkinson's disease(PD). 128 patient with PD will be recruited by the cluster sampling method for the two group pretest-posttest randomized controlled trial. The patient with PD will be allocated in two groups, Group therapy only (GTO) group and Group therapy with tDCS (GT-tDCS) treatment group by block randomization technique. Both GTO group and GT-tDCS group will receive the structured group therapy programme for one hour duration, twice a week for 6-weeks. In addition to the structured group therapy programme, GT-tDCS group will receive 20 minutes of tDCS application once a week for the 6-week duration. Data will be analysed at baseline, 3 weeks and 6 weeks of post intervention.
Detailed Description
Introduction:
Parkinson disease (PD) occurs due to degenerative changes in the nervous system, dysfunctions of basal ganglia. Patients affected with PD survive with the postural and mobility impairments that leads to impaired quality of life. Medical and surgical procedures do not provide the patient with a fully effective response.1 Literature suggests that physical therapy can improve the quality of life and balance function in patients with PD. Group therapy (GT) intervention is found to be significant intervention in aspects of mobility in various neurological conditions. GT have been used as part of supervised group rehabilitation to improve balance in patient with PD.2 Patients with PD have difficulties with learning of new motor skills, but recent neuro-modulatory techniques by noninvasive brain stimulation helps to facilitate motor skills and regulate neuroplasticity.
Transcranial direct current stimulation (tDCS) is a therapeutic device that is used to improve motor symptoms of PD, when applied to primary motor cortex M1. Anodal tDCS can increase M1 excitability, reduce cortical inhibition and results in improved functional performance. When combined with other exercise training, it provides longer lasting effect in motor function.3 However, no studies have investigated the concurrent use of anodal tDCS and group therapy intervention in patient with PD.
The aims of this study are to determine the effects of a 3 weeks concurrent GT and anodal tDCS intervention on measures of static and dynamic balance and to evaluate any long-term effects.
The investigators hypothesize that the combination of group therapy and anodal tDCS will improve balance and quality of life than group therapy or anodal tDCS alone.
Methodology of the proposed study Ethical statement and Subject recruitment The study protocol was approved by the institutional research advisory committee (RAC) and registered under the Universal Trial Number (UTN), U1111-1240-0949. The protocol will be registered under ClinicalTrials.gov, under World Health Organization International Clinical Trials Registry Platform and then the study will be submitted for the ethical approval by institutional ethics committee of Maharishi Markandeshwar Deemed to Be University, Mullana, and Haryana with unique reference number. The study will be executed in accordance with the principles of the Declaration of Helsinki (Revised, 2013) and National ethical guidelines for Biomedical and Health research involving human participants by Indian council for medical research (ICMR, 2017). The purpose of the study will be clearly explained to the patient with PD. Written informed consent form will be obtained from the recruited patients. The study will be performed between October, 2019 and March, 2022.
Inclusion Criteria
Presence of mild neurocognitive disorders was based on the validated Montreal Cognitive Assessment (MoCA) cutoff scores (<23.5)
Based on the Hoehn-Yahr Stage (HYS) staging, severity of PD was categorized as mild (HYS 1&2), moderate (HYS 3) and severe (HYS 4&5). Patient with PD with mild and moderate will be recruited Exclusion Criteria
Patient with PD with associated comorbidities such as stroke, uncontrolled diabetes, sensory impairments such as hearing, vision, etc.
Patient with PD who is not willing to participate in the study Total of X patient with PD will be screened and through convenience sampling method, 34 children will be selected based on the inclusion criteria for the two group pretest-posttest randomized controlled trial. Demographic data will be recorded for all the recruited patient with PD. The patient with PD will be allocated in two groups, Group therapy only (GTO) group and Group therapy with tDCS (GT-tDCS) treatment group by block randomization technique. The total required sample size of, n=128 will be randomized into both the groups. According to it, there will be four blocks, with the matrix design of 4 × 32, where32 being rows. Each row could have four blocks, with one chit (SNOSE - sequentially numbered, opaque sealed, envelopes) in each block containing either the name of GTO group or GT-tDCS group. Total four chits (2 chits for each group) will be assigned to each row and then patient with PD will be allotted to one of the two group based on the randomly chosen chit (SNOSE). Once the entire first row will be allotted, then the next row block will be opened for enrolment. The advantage of this method of randomization is that the number of patients assigned to each group over time would have been approximately equal. By this the unequal allocation of sample size, will be avoided. The concealed allocation of patient with PD to the treatment groups will be explained by using SNOSE.
Both GTO group and GT-tDCS group will receive the structured group therapy programme for one hour duration, twice a week for 6-weeks. In addition to the structured group therapy programme, GT-tDCS group will receive 20 minutes of tDCS application once a week for the 6-week duration. Outcomes will be used to analysed the data at baseline, 3 weeks and 6 weeks post intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
tDCS, Quality of Life, Parkinson Disease, Neuronal Plasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group therapy only (GTO)
Arm Type
Experimental
Arm Description
Patients in GTO group will receive structured group therapy programme
Arm Title
Group therapy with tDCS (GT-tDCS)
Arm Type
Experimental
Arm Description
Patients in this group will receive group therapy along-with tDCS intervention
Intervention Type
Other
Intervention Name(s)
GTO
Intervention Description
Forward direction activity: Balance activity in forward direction on wooden balance board (5 reps X 3 sets X 2 days in a week, for 6 weeks)
Backward direction activity: Balance activity in backward direction on wooden balance board (5 reps X 3 sets X 2 days in a week, for 6 weeks)
Sideways direction activity: Balance activity in sideways direction on wooden balance board (5 reps X 3 sets X 2 days in a week, for 6 weeks)
Intervention Type
Other
Intervention Name(s)
GT-tDCS
Intervention Description
Group therapy
Forward direction activity: Balance activity in forward direction on wooden balance board (5 reps X 3 sets X 2 days in a week, for 6 weeks)
Backward direction activity: Balance activity in backward direction on wooden balance board (5 reps X 3 sets X 2 days in a week, for 6 weeks)
Sideways direction activity: Balance activity in sideways direction on wooden balance board (5 reps X 3 sets X 2 days in a week, for 6 weeks)
tDCS Left anodal and right cathodal tDCS : Anode- F3, Cathode- Right Supra orbital area, Intensity- 2mA, Duration- 30 minutes, once in a week for 6 weeks
Primary Outcome Measure Information:
Title
Movement Disorders Society Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
Description
The Unified Parkinson Disease Rating Scale, designed to monitor the burden and extent of Parkinson's disease. o-4 score, lower the score indicates normal, higher the scores indicate greater impact of PD symptoms.
Time Frame
Change will be measured at baseline, 3 weeks and after 6 weeks of intervention
Title
Parkinson's Disease Questionnaire with 39 items
Description
The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month.
Assesses how often patients experience difficulties across the 8 quality of life dimensions.
Assesses impact of Parkinson's Disease (PD) on specific dimensions of functioning and well-being. Each dimension total score ranges from 0 (never have difficulty) to 100 (always have difficulty). lower score reflect better quality of life.
Time Frame
Change will be measured at baseline, 3 weeks and after 6 weeks of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of mild neurocognitive disorders was based on the validated Montreal Cognitive Assessment (MoCA) cutoff scores (<23.5)
Based on the Hoehn-Yahr Stage (HYS) staging, severity of PD was categorized as mild (HYS 1&2), moderate (HYS 3) and severe (HYS 4&5). Patient with PD with mild and moderate will be recruited
Exclusion Criteria:
Patient with PD with associated comorbidities such as stroke, uncontrolled diabetes, sensory impairments such as hearing, vision, etc.
Patient with PD who is not willing to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asir J Samuel, MPT, (Ph.D)
Phone
8059930222
Email
asirjohnsamuel@mmumullana.org
First Name & Middle Initial & Last Name or Official Title & Degree
Adarsh K Srivastav, MPT
Phone
8618889003
Ext
8618889003
Email
adarsh.srivastav@mmumullana.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adarsh K Srivastav, MPT
Organizational Affiliation
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26308937
Citation
King LA, Wilhelm J, Chen Y, Blehm R, Nutt J, Chen Z, Serdar A, Horak FB. Effects of Group, Individual, and Home Exercise in Persons With Parkinson Disease: A Randomized Clinical Trial. J Neurol Phys Ther. 2015 Oct;39(4):204-12. doi: 10.1097/NPT.0000000000000101.
Results Reference
result
PubMed Identifier
27838447
Citation
Lattari E, Costa SS, Campos C, de Oliveira AJ, Machado S, Maranhao Neto GA. Can transcranial direct current stimulation on the dorsolateral prefrontal cortex improves balance and functional mobility in Parkinson's disease? Neurosci Lett. 2017 Jan 1;636:165-169. doi: 10.1016/j.neulet.2016.11.019. Epub 2016 Nov 9.
Results Reference
result
PubMed Identifier
26316552
Citation
Renner CIe, Outermans J, Ludwig R, Brendel C, Kwakkel G, Hummelsheim H. Group therapy task training versus individual task training during inpatient stroke rehabilitation: a randomised controlled trial. Clin Rehabil. 2016 Jul;30(7):637-48. doi: 10.1177/0269215515600206. Epub 2015 Aug 27.
Results Reference
result
PubMed Identifier
27425786
Citation
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for idiopathic Parkinson's disease. Cochrane Database Syst Rev. 2016 Jul 18;7(7):CD010916. doi: 10.1002/14651858.CD010916.pub2.
Results Reference
result
PubMed Identifier
31485305
Citation
Nero H, Franzen E, Stahle A, Benka Wallen M, Hagstromer M. Long-Term Effects of Balance Training on Habitual Physical Activity in Older Adults with Parkinson's Disease. Parkinsons Dis. 2019 Aug 7;2019:8769141. doi: 10.1155/2019/8769141. eCollection 2019.
Results Reference
result
Learn more about this trial
Group Therapy With Transcranial Direct Current Stimulation in Patients With Parkinson's Disease
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