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The Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Depression in Parkinson's Disease (PD)

Primary Purpose

Depression in Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression in Parkinson's Disease

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients with Parkinson's Disease who were diagnosed according to UK bank criteria for PD, Aged 45-75 years, with criteria for depression (BDI > or = 14), and consent obtained from the patient or his caregiver.

Exclusion Criteria:

  • History of repeated head injury
  • History of repeated cerebrovascular strokes
  • History of defined encephalitis
  • Oculogyric crisis, supranuclear gaze palsy
  • Family history of more than one relative
  • History of drug intake as antipsychotics or 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) exposure
  • Moderate and Severe depression (Hamilton Depression Rating Scale score >16)
  • severe dysautonomia
  • Cerebellar signs
  • Babinski sign
  • Strictly unilateral features after 3 years
  • Hydrocephalus or intracranial lesion on neuroimaging
  • We also excludes patients with intracranial metallic devices or with pacemakers or any other device.
  • patients with cognitive impairment (Mini-Mental Status Examination< 24)

Sites / Locations

  • Assuit University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Real rTMS

sham rTMS

Arm Description

Real rTMS high frequency stimulation (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses on the left DLPFC for 10 consecutive sessions totally over period of 10 days.

Sham rTMS high frequency stimulation (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses with coil perpendicular on scalp over the occipital cortex for 10 consecutive sessions totally over period of 10 days.

Outcomes

Primary Outcome Measures

changes in depression severity measurements
Depression severity changes measured by Hamilton Depression Rating Scale (HAMD)

Secondary Outcome Measures

Full Information

First Posted
July 21, 2019
Last Updated
July 23, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04030923
Brief Title
The Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Depression in Parkinson's Disease (PD)
Official Title
The Effect of High Frequency Repetitive Transcranial Magnetic Stimulation on Depression in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut 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
This study aims to assess the therapeutic role of rTMS on parkinson's patients with depression. Patients diagnosed with Parkinson's Disease and depression will be recruited. All patients will be admitted and will be allocated randomly into two groups one of which will receive real sessions of high frequency rTMS for left dorsolateral prefrontal cortex (DLPFC) for 10 consecutive sessions totally over period of 10 days with repeated booster sessions every month during the period of follow up. The other will receive sham sessions.
Detailed Description
This study aims to assess the therapeutic role of rTMS on parkinson's patients with depression. Thirty PD patients with depression using United Kingdom (UK ) bank criteria for PD will be recruited from outpatient clinic in Assiut University. All patients will be admitted at Neuropsychiatric Department, Assiut University Hospital/ Assiut, Egypt.Each patient fulfilled the inclusion criteria as having score more than or equal 14 on Beck Depression Inventory (BDI) will be recruited. The patients will be allocated randomly into two groups one of which will receive real sessions of high frequency rTMS (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses for left DLPFC for 10 consecutive sessions totally over period of 10 days with repeated booster session every month during the period of follow up among three months. The other will receive sham sessions. All subjects will be followed up by selected clinical rating scales at different intervals pre session, post 10 sessions, and after one, two and three months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression in Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real rTMS
Arm Type
Active Comparator
Arm Description
Real rTMS high frequency stimulation (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses on the left DLPFC for 10 consecutive sessions totally over period of 10 days.
Arm Title
sham rTMS
Arm Type
Sham Comparator
Arm Description
Sham rTMS high frequency stimulation (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses with coil perpendicular on scalp over the occipital cortex for 10 consecutive sessions totally over period of 10 days.
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation
Intervention Description
By defining intensity of 80% of the resting Motor Threshold detected from motor area for Rt Abductor Pollicis Brevis (APB), we will apply repetitive Transcranial Magnetic Stimulation (rTMS) using 70-mm diameter air-cooled figure-of-8 coil and SuperRapid2 Magnetic Stimulator with high frequency (25Hz), Stimuli will be delivered for total 2000 pulse (divided on 50 trains with 40 pulses per train with inter-train interval 30 seconds) for the left DLPFC (coil placed tangential over the optimal position of 7 cm anterior to hand motor hotspot area detected for Real group and the same coil placed perpendicular with hand of coil pointing upward over occipital cortex for Sham group). Sessions will be consecutive for ten days period with repetition of consecutive 5 sessions as boosting doses on 5 days period over the follow up visits every month for the next 3 months.
Primary Outcome Measure Information:
Title
changes in depression severity measurements
Description
Depression severity changes measured by Hamilton Depression Rating Scale (HAMD)
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients with Parkinson's Disease who were diagnosed according to UK bank criteria for PD, Aged 45-75 years, with criteria for depression (BDI > or = 14), and consent obtained from the patient or his caregiver. Exclusion Criteria: History of repeated head injury History of repeated cerebrovascular strokes History of defined encephalitis Oculogyric crisis, supranuclear gaze palsy Family history of more than one relative History of drug intake as antipsychotics or 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) exposure Moderate and Severe depression (Hamilton Depression Rating Scale score >16) severe dysautonomia Cerebellar signs Babinski sign Strictly unilateral features after 3 years Hydrocephalus or intracranial lesion on neuroimaging We also excludes patients with intracranial metallic devices or with pacemakers or any other device. patients with cognitive impairment (Mini-Mental Status Examination< 24)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Khedr, professor
Organizational Affiliation
Neurology Department, Faculty of Medicine, Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assuit University
City
Assuit
ZIP/Postal Code
11517
Country
Egypt

12. IPD Sharing Statement

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The Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Depression in Parkinson's Disease (PD)

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