Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Group Therapy With Transcranial Direct Current Stimulation in Patients With Parkinson's Disease (GTBQ-PD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04174573
Recruitment Status : Not yet recruiting
First Posted : November 22, 2019
Last Update Posted : October 1, 2021
Sponsor:
Information provided by (Responsible Party):
Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: GTO Other: GT-tDCS Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 6, 2022
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group therapy only (GTO)
Patients in GTO group will receive structured group therapy programme
Other: GTO
  1. 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)
  2. 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)
  3. 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)

Experimental: Group therapy with tDCS (GT-tDCS)
Patients in this group will receive group therapy along-with tDCS intervention
Other: GT-tDCS
  1. Group therapy

    1. 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)
    2. 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)
    3. 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)
  2. 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 Measures :
  1. Movement Disorders Society Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS). [ Time Frame: Change will be measured at baseline, 3 weeks and after 6 weeks of intervention ]
    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.

  2. Parkinson's Disease Questionnaire with 39 items [ Time Frame: Change will be measured at baseline, 3 weeks and after 6 weeks of intervention ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04174573


Contacts
Layout table for location contacts
Contact: Asir J Samuel, MPT, (Ph.D) 8059930222 asirjohnsamuel@mmumullana.org
Contact: Adarsh K Srivastav, MPT 8618889003 ext 8618889003 adarsh.srivastav@mmumullana.org

Sponsors and Collaborators
Maharishi Markendeswar University (Deemed to be University)
Investigators
Layout table for investigator information
Principal Investigator: Adarsh K Srivastav, MPT Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Publications of Results:
Layout table for additonal information
Responsible Party: Asir John Samuel, Associate Professor, Maharishi Markendeswar University (Deemed to be University)
ClinicalTrials.gov Identifier: NCT04174573    
Other Study ID Numbers: U1111-1240-0949
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: October 1, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asir John Samuel, Maharishi Markendeswar University (Deemed to be University):
tDCS
Quality of Life
Parkinson Disease
Neuronal Plasticity
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases